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510(k) K930940

LUKENS STAINLESS STEEL SURGICAL SUTURE by Lukens Medical Corp. — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1993
Date Received
February 23, 1993
Clearance Type
Traditional
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 Lukens Medical Corp.

  • K965162 — LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRA (February 12, 1997)
  • K930943 — LUKENS NYLON SURGICAL SUTURE (December 17, 1993)
  • K930941 — LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE (December 17, 1993)
  • K930944 — LUKENS SURGICAL GUT SUTURE (December 17, 1993)
  • K930945 — BRAIDED POLYESTER SURGICAL SUTURE (December 17, 1993)
  • K930942 — LUKENS SILK SURGICAL SUTURE (December 17, 1993)
  • K904535 — LU-TEX II (January 30, 1991)

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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)
  • K082828 — SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (October 14, 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)