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510(k) K905287

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

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, Silk
Device Class
Class II
Regulation Number
878.5030
Review Panel
SU
Submission Type

Other clearances by Internacional Farmaceutica, S.A. DE C.V.

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  • 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)
  • K905286 — IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES (February 11, 1991)
  • K905285 — IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (February 11, 1991)

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  • K232355 — Non absorbable Surgical Silk Suture (January 16, 2024)
  • K221767 — Surgical Sutures with or without Needle (July 31, 2023)
  • K180701 — SafePath Suturing System (June 25, 2018)
  • K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (October 20, 2017)
  • K162396 — SILK Surgical Suture (November 23, 2016)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)