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510(k) K101252

NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 by Neotract, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2010
Date Received
May 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

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