The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for 8810 Pump-pump Single Needle Device.
| Device ID | K873279 |
| 510k Number | K873279 |
| Device Name: | 8810 PUMP-PUMP SINGLE NEEDLE DEVICE |
| Classification | Set, Dialysis, Single Needle With Uni-directional Pump |
| Applicant | CD MEDICAL, INC. 13520 S.E. PHEASANT CT. Portland, OR 97222 |
| Contact | Albert E Jarvis,phd |
| Correspondent | Albert E Jarvis,phd CD MEDICAL, INC. 13520 S.E. PHEASANT CT. Portland, OR 97222 |
| Product Code | FIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-17 |
| Decision Date | 1987-10-23 |