Cleared Traditional

AESCULAP SKIN GRAFT MESHER

K936186 · Aesculap, Inc. · General & Plastic Surgery
Mar 1994
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K936186 is an FDA 510(k) clearance for the AESCULAP SKIN GRAFT MESHER, a Expander, Surgical, Skin Graft (Class I — General Controls, product code FZW), submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 10, 1994, 77 days after receiving the submission on December 23, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K936186 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1993
Decision Date March 10, 1994
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FZW — Expander, Surgical, Skin Graft
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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