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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 K023959
Device Name JEROME GLASS RING
Applicant
The Jerome Group, Inc.
305 Harper Dr.
Moorestown,  NJ  08057
Applicant Contact BERNIE TATRO
Correspondent
The Jerome Group, Inc.
305 Harper Dr.
Moorestown,  NJ  08057
Correspondent Contact BERNIE TATRO
Regulation Number882.5960
Classification Product Code
HAX  
Date Received11/27/2002
Decision Date 02/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
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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