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510(k) K120827

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) by Angiotech — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2012
Date Received
March 19, 2012
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

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  • K073672 — SKATER BILIARY CATHETER (January 24, 2008)
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