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510(k) K895579

POLYSORB SYNTHETIC ABSORBABLE SUTURE by United States Surgical, A Division of Tyco Healthc — Product Code GAN

Clearance Details

Decision
SN ()
Decision Date
July 5, 1990
Date Received
September 15, 1989
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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  • K040594 — HERCULON SOFT TISSUE REATTACHMENT SYSTEM (March 31, 2004)
  • K032696 — AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& O (December 1, 2003)

Other clearances for product code GAN

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  • 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)
  • K920978 — ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED (February 15, 1994)
  • K900198 — DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. (July 5, 1990)