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FDA 510(k) Application Details - K133356
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
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510(K) Number
K133356
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE, NJ 08876-0151 US
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Contact
ELLIOTT JANG
Other 510(k) Applications for this Contact
Regulation Number
878.5010
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Classification Product Code
GAW
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More FDA Info for this Product Code
Date Received
10/31/2013
Decision Date
12/06/2013
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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