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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K102028
Device Name NEOTRACT ANCHOR SYSTEM MODEL TAS400
Applicant
Neotract, Inc.
4473 Willow Rd., Suite 100
Pleasanton,  CA  94588
Applicant Contact KEVIN F MACDONALD
Correspondent
Neotract, Inc.
4473 Willow Rd., Suite 100
Pleasanton,  CA  94588
Correspondent Contact KEVIN F MACDONALD
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
GDW  
Date Received07/19/2010
Decision Date 08/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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