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FDA 510(k) Application Details - K050337
Device Classification Name
Mesh, Surgical
More FDA Info for this Device
510(K) Number
K050337
Device Name
Mesh, Surgical
Applicant
COOK BIOTECH, INC.
1425 INNOVATION PLACE
WEST LAFAYETTE, IN 47906-1000 US
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Contact
MARK BLEYER
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
FTM
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More FDA Info for this Product Code
Date Received
02/10/2005
Decision Date
03/09/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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