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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K882877
Device Name JMS CERVICAL TRACTION DEVICE/HALO DEVICE
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 Number888.3040
Classification Product Code
JEC  
Date Received07/11/1988
Decision Date 09/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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