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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Irradiator, Blood To Prevent Graft Versus Host Disease
510(k) Number K974210
Device Name SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
Applicant
RAD-SOURCE, INC.
475 RAMBLEWOOD DR., SUITE 207
CORAL SPRINGS,  FL  33071
Applicant Contact RANDOL E KIRK
Correspondent
RAD-SOURCE, INC.
475 RAMBLEWOOD DR., SUITE 207
CORAL SPRINGS,  FL  33071
Correspondent Contact RANDOL E KIRK
Classification Product Code
MOT  
Date Received11/10/1997
Decision Date 03/30/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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