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510(k) K964072

MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED by Ethicon, Inc. — Product Code GAN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1996
Date Received
October 11, 1996
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)
  • K960653 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) (March 28, 1996)
  • K951231 — ORTHOPEDIC PACKS (December 1, 1995)
  • K920978 — ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED (February 15, 1994)
  • K895579 — POLYSORB SYNTHETIC ABSORBABLE SUTURE (July 5, 1990)
  • K900198 — DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. (July 5, 1990)