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510(k) K063603

SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 by Suturtek Incorporated — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2007
Date Received
December 3, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type

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  • K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE (March 17, 2003)

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  • K081060 — FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (December 24, 2008)
  • K082828 — SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (October 14, 2008)
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  • K041333 — SYNTHES (USA) TITANIUM WIRE (August 27, 2004)