Cleared Traditional

SKIN CLOSURE

K840945 · Gainor Medical · General & Plastic Surgery
Oct 1984
Decision
240d
Days
Class 1
Risk

About This 510(k) Submission

K840945 is an FDA 510(k) clearance for the SKIN CLOSURE, a Strip, Adhesive, Closure, Skin (Class I — General Controls, product code FPX), submitted by Gainor Medical. The FDA issued a Cleared decision on October 31, 1984, 240 days after receiving the submission on March 5, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number K840945 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1984
Decision Date October 31, 1984
Days to Decision 240 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FPX — Strip, Adhesive, Closure, Skin
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5240

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