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510(k) K994002

PLAIN/CHROMIC CATGUT by Trading Consultants and Distributors Intl., Inc. — Product Code GAL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2000
Date Received
November 24, 1999
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 Trading Consultants and Distributors Intl., Inc.

  • K994001 — POLYGLYCOLIC ACID (February 9, 2000)
  • K993999 — SILK (February 4, 2000)
  • K993998 — NYLON (February 4, 2000)
  • K993997 — POLYPROPYLENE (February 4, 2000)
  • K994000 — POLYESTER (February 4, 2000)

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)