The following data is part of a premarket notification filed by Dayspring Medical, Inc. with the FDA for Vented Diakysate Port Ccap, Red Pliable Vinyl - Dayspring Medical Part No, Dpc101vs.
| Device ID | K991005 |
| 510k Number | K991005 |
| Device Name: | VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS |
| Classification | System, Blood, Extracorporeal And Accessories |
| 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 | LLB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-25 |
| Decision Date | 1999-06-22 |