The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Erypur B.
| Device ID | K864636 |
| 510k Number | K864636 |
| Device Name: | ERYPUR B |
| Classification | Microfilter, Blood Transfusion |
| Applicant | ORGANON TEKNIKA CORP. 5516 NICHOLSON LN. Kensington, TX 20895 |
| Contact | Robert D Wurzel |
| Correspondent | Robert D Wurzel ORGANON TEKNIKA CORP. 5516 NICHOLSON LN. Kensington, TX 20895 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-26 |
| Decision Date | 1987-01-14 |