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FDA 510(k) Application Details - K130422
Device Classification Name
Suture, Recombinant Technology
More FDA Info for this Device
510(K) Number
K130422
Device Name
Suture, Recombinant Technology
Applicant
TORNIER, INC.
10801 NESBITT AVENUE
BLOOMINGTON, MN 55437 US
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Contact
LAEL J PICKETT
Other 510(k) Applications for this Contact
Regulation Number
878.4494
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Classification Product Code
NWJ
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More FDA Info for this Product Code
Date Received
02/20/2013
Decision Date
04/04/2013
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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