The following data is part of a premarket notification filed by Dravon Medical, Inc. with the FDA for S3086 Arterial, S3087 Venous Neonatal Hemodialysis.
| Device ID | K873455 |
| 510k Number | K873455 |
| Device Name: | S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | DRAVON MEDICAL, INC. P.O. BOX 69, 11465 S.E. HIGHWAY 212 Clackamas, OR 97015 |
| Contact | Madalyn C Duncan |
| Correspondent | Madalyn C Duncan DRAVON MEDICAL, INC. P.O. BOX 69, 11465 S.E. HIGHWAY 212 Clackamas, OR 97015 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-28 |
| Decision Date | 1987-09-14 |