The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for Volumetric Infusion Pump.
| Device ID | K904518 |
| 510k Number | K904518 |
| Device Name: | VOLUMETRIC INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | KENDALL MCGAW LABORATORIES, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 |
| Contact | John D'angelo |
| Correspondent | John D'angelo KENDALL MCGAW LABORATORIES, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-03 |
| Decision Date | 1990-10-17 |