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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 K915767
Device Name MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS
Applicant
J. L. Shepherd and Assoc.
1010 Arroyo Ave.
San Fernando,  CA  91340 -1822
Applicant Contact MARY F SHEPHERD
Correspondent
J. L. Shepherd and Assoc.
1010 Arroyo Ave.
San Fernando,  CA  91340 -1822
Correspondent Contact MARY F SHEPHERD
Classification Product Code
MOT  
Date Received12/24/1991
Decision Date 07/12/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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