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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Traction
510(k) Number K844490
Device Name TRACTION ACCESSORIES
Applicant
Jerome Medical
102 Gaither Dr.
Mt Laurel,  NJ  08054
Applicant Contact SUZANNE B BEACHER
Correspondent
Jerome Medical
102 Gaither Dr.
Mt Laurel,  NJ  08054
Correspondent Contact SUZANNE B BEACHER
Regulation Number890.5925
Classification Product Code
ILZ  
Date Received11/20/1984
Decision Date 02/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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