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FDA 510(k) Application Details - K161726
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
More FDA Info for this Device
510(K) Number
K161726
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
ETHICON, INC.
ROUTE 22 WM P.O. BOX 151
SOMERVILLE, NJ 08876 US
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Contact
ENZA DESERIO
Other 510(k) Applications for this Contact
Regulation Number
878.4493
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Classification Product Code
GAM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2016
Decision Date
07/12/2016
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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