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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K840951
Device Name FIRST AID BANDAGE
Applicant
Gainor Medical
12520 Yellowhead Trl.
Applicant Contact MARK GAINOR
Correspondent
Gainor Medical
12520 Yellowhead Trl.
Correspondent Contact MARK GAINOR
Regulation Number880.5240
Classification Product Code
KGX  
Date Received03/05/1984
Decision Date 10/31/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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