FDA 510(k) Application Details - K012990

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K012990
Device Name Dressing, Wound, Collagen
Applicant BIOCORE MEDICAL TECHNOLOGIES, INC.
11800 TECH ROAD,
SUITE # 240
SILVER SPRING, MD 20904-1908 US
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Contact AJAY KUMAR
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 09/06/2001
Decision Date 10/24/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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