MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS

Irradiator, Blood To Prevent Graft Versus Host Disease

J. L. SHEPHERD AND ASSOC.

The following data is part of a premarket notification filed by J. L. Shepherd And Assoc. with the FDA for Model 109 Series Blood Products Irradiators.

Pre-market Notification Details

Device IDK915766
510k NumberK915766
Device Name:MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS
ClassificationIrradiator, Blood To Prevent Graft Versus Host Disease
Applicant J. L. SHEPHERD AND ASSOC. 1010 ARROYO AVE. San Fernando,  CA  91340 -1822
ContactMary F Shepherd
CorrespondentMary F Shepherd
J. L. SHEPHERD AND ASSOC. 1010 ARROYO AVE. San Fernando,  CA  91340 -1822
Product CodeMOT  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-24
Decision Date1995-07-12

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