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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K082956
Device Name ALPHA ORTHOPAEDICS AT2 SYSTEM
Applicant
Alpha Orthopaedics
23575 Cabot Blvd., Suite 2
Hayward,  CA  94545
Applicant Contact GINA TO
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact DAWN TIBODEAU
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/03/2008
Decision Date 12/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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