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FDA 510(k) Application Details - K110110
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K110110
Device Name
Mesh, Surgical, Polymeric
Applicant
ATRIUM MEDICAL CORPORATION
5 WENTWORTH DR
HUDSON, NH 03051 US
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Contact
RAYMOND J KELLY
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
01/14/2011
Decision Date
02/15/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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