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.
Device ID | K915766 |
510k Number | K915766 |
Device Name: | MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS |
Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
Applicant | J. L. SHEPHERD AND ASSOC. 1010 ARROYO AVE. San Fernando, CA 91340 -1822 |
Contact | Mary F Shepherd |
Correspondent | Mary F Shepherd J. L. SHEPHERD AND ASSOC. 1010 ARROYO AVE. San Fernando, CA 91340 -1822 |
Product Code | MOT |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-24 |
Decision Date | 1995-07-12 |