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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K811528
Device Name RADIATION BOLUS
Applicant
Action Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Action Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.5900
Classification Product Code
JAD  
Date Received06/01/1981
Decision Date 07/10/1981
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
Recalls CDRH Recalls
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