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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tong, Skull For Traction
510(k) Number K071173
Device Name RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
Applicant
Ossur Americans (Formerly the Jerome Group)
1414 Metropolitan Ave.
Paulsboro,  NJ  08066
Applicant Contact BERNIE TATRO
Correspondent
Ossur Americans (Formerly the Jerome Group)
1414 Metropolitan Ave.
Paulsboro,  NJ  08066
Correspondent Contact BERNIE TATRO
Regulation Number882.5960
Classification Product Code
HAX  
Date Received04/27/2007
Decision Date 05/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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