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510(k) K113800

QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE by Angiotech — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2012
Date Received
December 23, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

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