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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 K864076
Device Name HERCON ANTISEPTIC TRANSPARENT DRESSING
Applicant
Hercon Laboratories Corp.
200b Corporate Court
Middlesex Business Center
So. Plainfield,  NJ  07080
Applicant Contact LAURA T ZEOLI
Correspondent
Hercon Laboratories Corp.
200b Corporate Court
Middlesex Business Center
So. Plainfield,  NJ  07080
Correspondent Contact LAURA T ZEOLI
Regulation Number880.5240
Classification Product Code
KGX  
Date Received10/20/1986
Decision Date 12/29/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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