FDA 510(k) Application Details - K042606

Device Classification Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

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510(K) Number K042606
Device Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI, PA 19301 US
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Contact KATHY ANDERSON
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Regulation Number 878.4495

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Classification Product Code GAQ
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Date Received 09/24/2004
Decision Date 05/27/2005
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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