The following data is part of a premarket notification filed by Dayspring Medical, Inc. with the FDA for Pump Segment Rinse Line W/ Slip-on Connector, Pump Segment Rinse Line W/ Luer-lock Connector, T-connector, Short, W/ Sli.
| Device ID | K991003 |
| 510k Number | K991003 |
| Device Name: | PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI |
| Classification | Connector, Tubing, Dialysate |
| 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 | FKY |
| 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 | 1999-06-09 |