The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for Seraflo(tm) Bloodlines For Hemodialysis.
| Device ID | K864784 |
| 510k Number | K864784 |
| Device Name: | SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Jarvis, Ph.d. |
| Correspondent | Jarvis, Ph.d. CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-08 |
| Decision Date | 1987-01-20 |