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FDA 510(k) Application Details - K012997
Device Classification Name
Dressing, Wound And Burn, Occlusive
More FDA Info for this Device
510(K) Number
K012997
Device Name
Dressing, Wound And Burn, Occlusive
Applicant
BIOCORE MEDICAL TECHNOLOGIES, INC.
11800 TECH ROAD,
SUITE # 240
SILVER SPRING, MD 20904-1908 US
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Contact
AJAY KUMAR
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MGP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/06/2001
Decision Date
10/25/2001
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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