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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 K893168
Device Name SPINALATOR JS-1100 TRACTION UNIT
Applicant
THE SPINALATOR CO.
3177 SWEETEN CREEK RD.
ASHEVILLE,  NC  28803
Applicant Contact HAROLD C ENLOE
Correspondent
THE SPINALATOR CO.
3177 SWEETEN CREEK RD.
ASHEVILLE,  NC  28803
Correspondent Contact HAROLD C ENLOE
Regulation Number890.5900
Classification Product Code
ITH  
Date Received04/14/1989
Decision Date 05/26/1989
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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