Cleared Traditional

MICROPOROUS HYPOALLERGENIC

K840946 · Gainor Medical · General & Plastic Surgery
Aug 1984
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K840946 is an FDA 510(k) clearance for the MICROPOROUS HYPOALLERGENIC, a Ring (wound Protector), Drape Retention, Internal (Class II — Special Controls, product code KGW), submitted by Gainor Medical. The FDA issued a Cleared decision on August 17, 1984, 165 days after receiving the submission on March 5, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K840946 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1984
Decision Date August 17, 1984
Days to Decision 165 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KGW — Ring (wound Protector), Drape Retention, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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