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510(k) K053380

CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE by Surgical Specialties Corp — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2006
Date Received
December 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

Other clearances by Surgical Specialties Corp

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  • K140227 — MONODERM SURGICAL SUTURE (February 28, 2014)
  • 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)
  • K052962 — OPTIMIZED BARB DESIGN (December 6, 2005)
  • K052437 — MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE (November 7, 2005)

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