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510(k) K003015

SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD by Surgical Specialties Corp — Product Code GAN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2000
Date Received
September 27, 2000
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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  • K080985 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) (April 23, 2008)
  • K080680 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE (March 21, 2008)
  • K071989 — QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL (August 6, 2007)
  • K072028 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM (August 3, 2007)
  • K063680 — SHARPOINT PDO (POLYDIOXANONE) SUTURES (May 9, 2007)
  • K053380 — CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE (January 18, 2006)
  • K052962 — OPTIMIZED BARB DESIGN (December 6, 2005)

Other clearances for product code GAN

  • 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)
  • K895579 — POLYSORB SYNTHETIC ABSORBABLE SUTURE (July 5, 1990)
  • K900198 — DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. (July 5, 1990)