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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K060670
Device Name ACCIN UNI-KNEE SYSTEM
Applicant
Accin Corporation
1033 Us Hwy. 46e
Suite A204
Clifton,  NJ  07013
Applicant Contact MICHAEL KVITNITSKY
Correspondent
Accin Corporation
1033 Us Hwy. 46e
Suite A204
Clifton,  NJ  07013
Correspondent Contact MICHAEL KVITNITSKY
Regulation Number888.3520
Classification Product Code
HSX  
Date Received03/14/2006
Decision Date 06/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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