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27HJ713S

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Generic:Laparoscope, General & Plastic Surgery
Manufacturer:Lg Electronics
Drug Classes:Not Available
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27HJ713S

Generic:Laparoscope, General & Plastic Surgery
Manufacturer:Lg Electronics
Drug Classes:Not Available
Reps:
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Rep 2Signup or Login to view Reps
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Synopsis
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DescriptionIndication and Usage
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Synopsis
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Disclaimer: The synopsis and product information provided on Alpha.MD are derived from openFDA data and are for informational purposes only. This information may not be comprehensive, accurate, or up-to-date. Clinicians should exercise their own professional judgment in interpreting and using this information, and consult the official prescribing information for the most accurate and current details.
Description

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Indication and Usage

CFR 807.92(a)(5)] This 27HJ713S is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems. This product does not support 3D. 7.

Approval History
FDA approved 2017
Includes history for all formulations of adalimumab
May 30, 2017
(Type 2 New Active Ingredient and Type 4 New Combination)
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