The following data is part of a premarket notification filed by Advocacy International, Ltd. with the FDA for Sepacell R-500 And Sepacell R-500a.
| Device ID | K873792 |
| 510k Number | K873792 |
| Device Name: | SEPACELL R-500 AND SEPACELL R-500A |
| Classification | Microfilter, Blood Transfusion |
| Applicant | ADVOCACY INTERNATIONAL, LTD. INTERNATIONA SQUARE 1825 EYE STREET N.W. SUITE 400 Washington, DC 20006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney ADVOCACY INTERNATIONAL, LTD. INTERNATIONA SQUARE 1825 EYE STREET N.W. SUITE 400 Washington, DC 20006 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-17 |
| Decision Date | 1988-01-19 |