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FDA 510(k) Application Details - K960219
Device Classification Name
Mesh, Surgical, Polymeric
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510(K) Number
K960219
Device Name
Mesh, Surgical, Polymeric
Applicant
ADVANCED SURGICAL INNOVATIONS, INC.
6890 PACIFIC CIRCLE
MISSISSAUGA, ONTARIO L5TIN8 CA
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Contact
DAVID M OLSEN
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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
01/16/1996
Decision Date
03/15/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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