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FDA 510(k) Application Details - K102965
Device Classification Name
More FDA Info for this Device
510(K) Number
K102965
Device Name
CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
Applicant
MEDTRADE PRODUCTS LTD.
ELECTRA HOUSE
CREWE BUSINESS PARK CREWE
CHESHIRE CW1 6GL GB
Other 510(k) Applications for this Company
Contact
JONATHAN D RANFIELD
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/05/2010
Decision Date
12/08/2010
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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