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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ring (wound protector), drape retention, internal
510(k) Number K840946
Device Name MICROPOROUS HYPOALLERGENIC
Applicant
GAINOR MEDICAL
12520 YELLOWHEAD TRAIL
Correspondent
GAINOR MEDICAL
12520 YELLOWHEAD TRAIL
Regulation Number878.4370
Classification Product Code
KGW  
Date Received03/05/1984
Decision Date 08/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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