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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 K851828
Device Name IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C
Applicant
SYNCOR INTL. CORP.
12847 ARROYO ST.
SYLMAR,  CA  91342
Applicant Contact ELEANOR V CHIU
Correspondent
SYNCOR INTL. CORP.
12847 ARROYO ST.
SYLMAR,  CA  91342
Correspondent Contact ELEANOR V CHIU
Classification Product Code
MOT  
Date Received04/26/1985
Decision Date 09/19/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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