FDA 510(k) Application Details - K052953

Device Classification Name Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)

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510(K) Number K052953
Device Name Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
Applicant ETHICON, INC.
RT. 22 WEST
P.O. BOX 151
SOMERVILLE, NJ 08876 US
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Contact JENNIFER M PAINE
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Regulation Number 878.5010

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Classification Product Code MXW
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Date Received 10/20/2005
Decision Date 03/06/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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