The following data is part of a premarket notification filed by Mckinley, Inc. with the FDA for Mckinley Sp Disposable Infusion Pump.
| Device ID | K990461 |
| 510k Number | K990461 |
| Device Name: | MCKINLEY SP DISPOSABLE INFUSION PUMP |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | MCKINLEY, INC. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | John Mcinroy |
| Correspondent | John Mcinroy MCKINLEY, INC. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-12 |
| Decision Date | 1999-06-30 |