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510(k) K935435

NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST by Victoreen, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1994
Date Received
November 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K940660 — MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM (December 9, 1994)
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  • K934549 — ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD (February 19, 1994)

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