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FDA 510(k) Application Details - K982532
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K982532
Device Name
Mesh, Surgical, Polymeric
Applicant
COGENT
555 THIRTEENTH ST. N.W.
WASHINGTON, DC 20004 US
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Contact
HOWARD M HOLSTEIN
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
07/20/1998
Decision Date
01/20/1999
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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