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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixation Accessory
510(k) Number K040363
Device Name CERAMIC TIPPED SKULL PIN
Applicant
The Jerome Group, Inc.
305 Harper Dr.
Moorestown,  NJ  08057
Applicant Contact RONALD KOWALSKI
Correspondent
The Jerome Group, Inc.
305 Harper Dr.
Moorestown,  NJ  08057
Correspondent Contact RONALD KOWALSKI
Regulation Number888.3030
Classification Product Code
LYT  
Date Received02/13/2004
Decision Date 04/12/2004
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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