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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 K862846
Device Name TEC VARI-TRAC II TRACTION UNIT
Applicant
THERAPEUTIC EQUIPMENT CORP.
60 PAGE RD.
CLIFTON,  NJ  07012
Applicant Contact ALAN P SCHWARTZ
Correspondent
THERAPEUTIC EQUIPMENT CORP.
60 PAGE RD.
CLIFTON,  NJ  07012
Correspondent Contact ALAN P SCHWARTZ
Regulation Number890.5900
Classification Product Code
ITH  
Date Received07/29/1986
Decision Date 08/07/1986
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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