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510(k) K122898

QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN by Surgical Specialties Corp. Dba Angiotech — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2012
Date Received
September 21, 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 Surgical Specialties Corp. Dba Angiotech

  • K133420 — TRANQUILL BARBED DEVICE (November 29, 2013)
  • K131224 — SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUI (May 16, 2013)
  • K130078 — QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (February 28, 2013)
  • K123877 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (January 2, 2013)
  • K123836 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (December 21, 2012)
  • K123409 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (November 20, 2012)

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