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510(k) K920978

ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED by Ethicon, Inc. — Product Code GAN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1994
Date Received
March 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic
Device Class
Class II
Regulation Number
878.4830
Review Panel
SU
Submission Type

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Other clearances for product code GAN

  • K003015 — SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD (December 15, 2000)
  • K964072 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED (December 18, 1996)
  • K960653 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) (March 28, 1996)
  • K951231 — ORTHOPEDIC PACKS (December 1, 1995)
  • K895579 — POLYSORB SYNTHETIC ABSORBABLE SUTURE (July 5, 1990)
  • K900198 — DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. (July 5, 1990)