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510(k) K133890

AESCULAP OPTILENE NONABSORBABLE SUTURE by Aesculap, Inc. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2014
Date Received
December 20, 2013
Clearance Type
Traditional
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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