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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 K800761
Device Name POINT TO POINT LEVEL
Applicant
Radiation Products Design, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Radiation Products Design, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/04/1980
Decision Date 05/14/1980
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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