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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
Original Applicant
BASF VENTURE CAPITAL AMERICA INC.
100 campus drive
floram park,  NJ  07932
Original Contact nadi ergenc, ph.d.
Classification Product Code
FRO  
Date Received07/31/2012
Decision Date 08/28/2012
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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