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510(k) K974210

SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 by Rad-Source, Inc. — Product Code MOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1998
Date Received
November 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class
Class U
Regulation Number
Review Panel
RA
Submission Type

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  • K952291 — GAMMACELL 3000 ELAN (August 25, 1995)