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510(k) K060721

LARIAT LOOP APPLICATOR by Sentreheart — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2006
Date Received
March 17, 2006
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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