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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K960686
Device Name HYCOAT
Applicant
The Hymed Group Corp.
1890 Bucknell Dr.
Bethlehem,  PA  18015
Applicant Contact GEORGE D PETITO
Correspondent
The Hymed Group Corp.
1890 Bucknell Dr.
Bethlehem,  PA  18015
Correspondent Contact GEORGE D PETITO
Classification Product Code
MGQ  
Date Received02/20/1996
Decision Date 08/12/1996
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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