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510(k) K911354

STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1991
Date Received
March 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Natural
Device Class
Class II
Regulation Number
878.4830
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)
  • K911189 — STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE (April 25, 1991)
  • K905287 — IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES (February 11, 1991)
  • K905285 — IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (February 11, 1991)
  • K905286 — IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES (February 11, 1991)

Other clearances for product code GAL

  • K142656 — Surgical Gut Suture (January 29, 2015)
  • K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (April 30, 2008)
  • K042287 — UNIPLAIN & UNICHROM (September 7, 2005)
  • K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE (November 19, 2004)
  • K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE (March 17, 2003)
  • K020597 — SERRALGUT (August 14, 2002)
  • K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (June 21, 2002)
  • K011105 — SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (May 30, 2001)
  • K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (June 23, 2000)
  • K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)