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510(k) K102028

NEOTRACT ANCHOR SYSTEM MODEL TAS400 by Neotract, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2010
Date Received
July 19, 2010
Clearance Type
Special
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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