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510(k) K040282

ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2004
Date Received
February 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
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)
  • 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)
  • K905285 — IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (February 11, 1991)

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