510(k) K811528

RADIATION BOLUS by Action Products, Inc. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Therapeutic, X-Ray
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type