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510(k) K905285

IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1991
Date Received
November 26, 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 Internacional Farmaceutica, S.A. DE C.V.

  • K072863 — ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES (May 23, 2008)
  • K072859 — ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES (May 23, 2008)
  • K041048 — POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE (June 4, 2004)
  • K040282 — ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID (April 29, 2004)
  • K913185 — STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT (December 4, 1991)
  • K911354 — STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES (October 25, 1991)
  • K911189 — STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE (April 25, 1991)
  • K905287 — IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES (February 11, 1991)
  • K905286 — IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES (February 11, 1991)

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)