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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K870743
Device Name HERCON ANTI. TRANS. DRESSING AS A WOUND DRESSING
Applicant
Hercon Laboratories Corp.
200b Corporate Ct.
Middlesex Business Center
So. Plainfield,  NJ  07080
Applicant Contact JANINE LAURENCOT
Correspondent
Hercon Laboratories Corp.
200b Corporate Ct.
Middlesex Business Center
So. Plainfield,  NJ  07080
Correspondent Contact JANINE LAURENCOT
Classification Product Code
FRO  
Date Received02/10/1987
Decision Date 04/06/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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