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510(k) K030212

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE by Genzyme Biosurgery — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2003
Date Received
January 21, 2003
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 Genzyme Biosurgery

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  • K022989 — RADLITE TISSUE RETRACTOR SYSTEM (November 25, 2002)
  • K022410 — SAPH-LOOP LIGATING LOOP (August 20, 2002)

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