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510(k) K063680

SHARPOINT PDO (POLYDIOXANONE) SUTURES by Surgical Specialties Corp — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2007
Date Received
December 11, 2006
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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  • K141558 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE (July 11, 2014)
  • 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)
  • K053380 — CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE (January 18, 2006)
  • K052962 — OPTIMIZED BARB DESIGN (December 6, 2005)
  • K052437 — MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE (November 7, 2005)

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