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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
Other 510(k) Applications for this Contact
Regulation Number
878.4495
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Classification Product Code
GAQ
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More FDA Info for this Product Code
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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