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510(k) K904054

POLYVIOLENE(TM) SUTURE by Look, Inc. — Product Code GAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1990
Date Received
July 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyester
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Look, Inc.

  • K943949 — POLYVIOLENE SURGICL SUTURE (November 10, 1994)
  • K933686 — LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE (December 23, 1993)
  • K926586 — REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES (December 22, 1993)
  • K926588 — REVISED LABELING FOR POLYPROPYLENE SUTURE (December 17, 1993)
  • K926168 — SILK SUTURES-REVISED LABELING (December 17, 1993)
  • K926167 — POLYVIOLENE SUTURE-REVISED LABELING (December 17, 1993)
  • K926587 — REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) (December 17, 1993)
  • K913530 — LOOK VISCODISSECTOR (October 21, 1991)
  • K903029 — STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE (October 25, 1990)
  • K903584 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (October 11, 1990)

Other clearances for product code GAS

  • K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK (November 24, 2020)
  • K203081 — RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (November 24, 2020)
  • K091018 — ARTHREX BIOWIRE (July 30, 2010)
  • K002261 — MR-III (October 23, 2000)
  • K953128 — SUTURE CORD (February 9, 1996)
  • K923161 — BRAIDED POLYESTER SUTURE MATERIAL (December 30, 1992)
  • K913101 — PETERS CARDIOFLON(TM) SUTURE (August 12, 1992)
  • K915089 — MITEK QUICKANCHOR(TM), MODIFICATION (February 3, 1992)
  • K915081 — MITEK SNAP PAK(TM), MODIFICATION (January 31, 1992)
  • K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (July 26, 1991)