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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K150382
Device Name Radio Therapy Treatment Chair
Applicant
Radiation Products Design, Inc.
5218 Barthel Industrial Dr.
Albertville,  MN  55301
Applicant Contact Howard Larson
Correspondent
Radiation Products Design, Inc.
5218 Barthel Industrial Dr.
Albertville,  MN  55301
Correspondent Contact Howard Larson
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/18/2015
Decision Date 09/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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