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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K934519
Device Name RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM
Applicant
Medtec, Inc.
1401 8th St. SE
P.O. Box 602
Orange City,  IA  51041
Applicant Contact DONALD RIIBE
Correspondent
Medtec, Inc.
1401 8th St. SE
P.O. Box 602
Orange City,  IA  51041
Correspondent Contact DONALD RIIBE
Regulation Number892.5780
Classification Product Code
IWE  
Date Received09/17/1993
Decision Date 12/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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