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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 K935760
Device Name TEC 2100 (MODEL MT-LPLGD)
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 Received11/26/1993
Decision Date 01/25/1994
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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