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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
Predetermined Change
Control Plan Authorized		 No
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