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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name equipment, traction, powered
510(k) Number K073132
Device Name MODEL D DISC FORCE
Applicant
NORTH AMERICAN MEDICAL CORP (NAM)
1649 SANDS PLACE S.E.
SUITE A
marietta,  GA  30067
Applicant Contact chello grace
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact mark job
Regulation Number890.5900
Classification Product Code
ITH  
Date Received11/07/2007
Decision Date 04/03/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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