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 |