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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 K930021
Device Name J TONGS
Applicant
Jerome Medical
102 Gaither Dr.
Mt Laurel,  NJ  08054
Applicant Contact DANIEL L CLEMENS
Correspondent
Jerome Medical
102 Gaither Dr.
Mt Laurel,  NJ  08054
Correspondent Contact DANIEL L CLEMENS
Regulation Number882.5960
Classification Product Code
HAX  
Date Received01/05/1993
Decision Date 12/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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