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510(k) K123940

DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE by Demetech Corp. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2014
Date Received
December 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

Other clearances by Demetech Corp.

  • K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (September 25, 2014)
  • K130083 — DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE (July 17, 2013)
  • K082097 — DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE (January 8, 2010)
  • K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (April 30, 2008)
  • K043330 — POLYPROPILENE SURGICAL SUTURES (May 16, 2005)
  • K043539 — DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES (April 6, 2005)
  • K033550 — DXL CALSCAN (May 5, 2004)
  • K023028 — DEMETECH NYLON NONABSORBABLE SUTURE (June 18, 2003)
  • K023030 — DEMETECH POLYESTER NONABSORBABLE SUTURE (June 18, 2003)
  • K023029 — DEMETECH SILK NONABSORBABLE SUTURE (November 25, 2002)

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