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510(k) K082828

SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE by Suturtek Incorporated — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2008
Date Received
September 25, 2008
Clearance Type
Special
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

Other clearances by Suturtek Incorporated

  • K063603 — SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (February 7, 2007)
  • K032468 — SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE (September 23, 2003)
  • K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE (March 17, 2003)

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  • K170767 — Surgical Stainless Steel Suture, Stainless Steel Suture (November 1, 2017)
  • K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (September 25, 2014)
  • K140127 — FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (May 28, 2014)
  • K081060 — FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (December 24, 2008)
  • K063603 — SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (February 7, 2007)
  • K042606 — MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE (May 27, 2005)
  • K041333 — SYNTHES (USA) TITANIUM WIRE (August 27, 2004)