The following data is part of a premarket notification filed by Dayspring Medical, Inc. with the FDA for Bllod Port Cap, Dialysate Port Cap, Vented Dialysate Port Cap With Red Pliable Vinyl.
| Device ID | K961039 |
| 510k Number | K961039 |
| Device Name: | BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | DAYSPRING MEDICAL, INC. 1936 BEACON CT. Boulder, CO 80302 |
| Contact | Neil Rasmussen |
| Correspondent | Neil Rasmussen DAYSPRING MEDICAL, INC. 1936 BEACON CT. Boulder, CO 80302 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-14 |
| Decision Date | 1996-09-12 |