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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 K002260
Device Name SPINA SYSTEM
Applicant
NORTH AMERICAN MEDICAL CORPORATION (NAM)
6595 ROSWELL RD. STE 811
atlanta,  GA  30328
Applicant Contact carlos becerra
Correspondent
NORTH AMERICAN MEDICAL CORPORATION (NAM)
6595 ROSWELL RD. STE 811
atlanta,  GA  30328
Correspondent Contact carlos becerra
Regulation Number890.5900
Classification Product Code
ITH  
Date Received07/25/2000
Decision Date 08/25/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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