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FDA 510(k) Application Details - K063091
Device Classification Name
Mesh, Surgical, Polymeric
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510(K) Number
K063091
Device Name
Mesh, Surgical, Polymeric
Applicant
TYRX PHARMA, INC.
1 DEER PARK DR.
SUITE G
MONMOUTH JUNCTION, NJ 08852 US
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Contact
MASON W DIAMOND
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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
10/10/2006
Decision Date
01/16/2008
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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