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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. STE. "G"
LAKE ELSINORE,  CA  92330
Applicant Contact BRADLEY T WILHEIM
Correspondent
I-REP, INC.
29885 SECOND ST. STE. "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
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