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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 K051918
Device Name RESOLVE OPEN BACK HALO RINGS
Applicant
Jerome Medical
305 Harper Dr.
Moorestown,  NJ  08057
Applicant Contact BERNIE TATRO
Correspondent
Jerome Medical
305 Harper Dr.
Moorestown,  NJ  08057
Correspondent Contact BERNIE TATRO
Regulation Number882.5960
Classification Product Code
HAX  
Date Received07/15/2005
Decision Date 08/17/2005
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
Recalls CDRH Recalls
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