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FDA 510(k) Application Details - K061704
Device Classification Name
Mesh, Surgical, Polymeric
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510(K) Number
K061704
Device Name
Mesh, Surgical, Polymeric
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact
LISA M BOYLE
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Regulation Number
878.3300
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Classification Product Code
FTL
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Date Received
06/16/2006
Decision Date
07/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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