Cleared Traditional

AMERICAN BRAIN RETRACTOR COVER

K872951 · American Silk Sutures, Inc. · General & Plastic Surgery
Sep 1987
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K872951 is an FDA 510(k) clearance for the AMERICAN BRAIN RETRACTOR COVER, a Motor, Surgical Instrument, Pneumatic Powered (Class I — General Controls, product code GET), submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on September 16, 1987, 50 days after receiving the submission on July 28, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K872951 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1987
Decision Date September 16, 1987
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GET — Motor, Surgical Instrument, Pneumatic Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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