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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 K951601
Device Name MED-TEC STRING RETICLE TRAY
Applicant
Medtec, Inc.
Salem Ave. & 8th St.
East Highway 10
Orange City,  IA  51041
Applicant Contact DONALD F RIIBE
Correspondent
Medtec, Inc.
Salem Ave. & 8th St.
East Highway 10
Orange City,  IA  51041
Correspondent Contact DONALD F RIIBE
Regulation Number892.5780
Classification Product Code
IWE  
Date Received04/07/1995
Decision Date 05/11/1995
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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