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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K941719
Device Name 360 DEG. ROTATING 1/2 BEAM BLOCK
Applicant
Medtec, Inc.
Salem Ave. & 8th St.
East Hwy. 10
Orange City,  IA  51041
Applicant Contact DONALD RIIBE
Correspondent
Medtec, Inc.
Salem Ave. & 8th St.
East Hwy. 10
Orange City,  IA  51041
Correspondent Contact DONALD RIIBE
Regulation Number892.5710
Classification Product Code
IXI  
Date Received04/07/1994
Decision Date 07/18/1994
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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