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510(k) K140039

POLYCRYL by Aurolab — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2014
Date Received
January 7, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

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