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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 K122297
Device Name ENLUXTRA HUMIFIBER WOUND DRESSING
Applicant
Basf Venture Capital America, Inc.
100 Campus Dr.
Florham Park,  NJ  07932
Applicant Contact NADI ERGENC, PH.D.
Correspondent
Basf Venture Capital America, Inc.
100 Campus Dr.
Florham Park,  NJ  07932
Correspondent Contact NADI ERGENC, PH.D.
Classification Product Code
FRO  
Date Received07/31/2012
Decision Date 08/28/2012
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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