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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 K984262
Device Name MODIFICATION OF BIONECT HYDROGEL GAUZE PADS
Applicant
Fidia Pharmaceutical Corp.
2000 K St.,N.W
Suite 700
Washington,  DC  20006
Applicant Contact ROBERTO FIORENTINI
Correspondent
Fidia Pharmaceutical Corp.
2000 K St.,N.W
Suite 700
Washington,  DC  20006
Correspondent Contact ROBERTO FIORENTINI
Classification Product Code
MGQ  
Date Received11/17/1998
Decision Date 02/10/1999
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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