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510(k) K002755

NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE by T. Korossurgical Instruments Corp. — Product Code LRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2000
Date Received
September 5, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Surgical
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by T. Korossurgical Instruments Corp.

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  • K954052 — ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES (November 6, 1995)
  • K954014 — PERCUTANEOUS DISCECTOMY CANNULA SYSTEM (November 6, 1995)
  • K935529 — CERVICAL SELF-RETAINING RETRACTOR (March 22, 1994)
  • K926585 — THOROCOSCOPY SELF-RETAINING RETRACTOR (August 6, 1993)
  • K926583 — REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR (August 6, 1993)
  • K931262 — REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR (August 6, 1993)
  • K931259 — ENDOSCOPIC OR THORASCOPIC FORCEPS (June 8, 1993)

Other clearances for product code LRN

  • K990355 — STAINLESS STEEL SOFT SUTURE WIRE (July 8, 1999)
  • K971682 — J-FX CERCLAGE SYSTEM (June 27, 1997)
  • K952783 — OXBORO-MEDICAL PIN COVERS (September 15, 1995)
  • K942603 — ORTHOPAEDIC WIRES (November 9, 1994)
  • K900926 — TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) (April 23, 1990)
  • K892651 — SONGER WIRING SYSTEM (July 25, 1989)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)