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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 K930691
Device Name ACCUTRAC TRACTION UNIT
Applicant
I-Rep, Inc.
29885 Second St. Suite "G"
Lake Elsinore,  CA  92330
Applicant Contact BRADLEY T WILHEIM
Correspondent
I-Rep, Inc.
29885 Second St. Suite "G"
Lake Elsinore,  CA  92330
Correspondent Contact BRADLEY T WILHEIM
Regulation Number890.5900
Classification Product Code
ITH  
Date Received02/10/1993
Decision Date 07/22/1993
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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