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510(k) K100876

AESCULAP MONOMAX ABSORBABLE SUTURE by Aesculap, Inc. — Product Code NWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2010
Date Received
March 30, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Recombinant Technology
Device Class
Class II
Regulation Number
878.4494
Review Panel
SU
Submission Type

Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.

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