The following data is part of a premarket notification filed by Mckinley, Inc. with the FDA for Beeline Motiv, Propolis, Pca.
| Device ID | K042228 |
| 510k Number | K042228 |
| Device Name: | BEELINE MOTIV, PROPOLIS, PCA |
| Classification | Pump, Infusion |
| Applicant | MCKINLEY, INC. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Michelle Pratte |
| Correspondent | Michelle Pratte MCKINLEY, INC. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-17 |
| Decision Date | 2004-11-08 |
| Summary: | summary |