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510(k) K180321

Aesculap Optilene Nonabsorbable Suture by Aesculap, Inc. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2018
Date Received
February 5, 2018
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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