The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Volumetric Infusion Pump, Modification.
| Device ID | K913056 |
| 510k Number | K913056 |
| Device Name: | VOLUMETRIC INFUSION PUMP, MODIFICATION |
| Classification | Pump, Infusion |
| Applicant | MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 -9791 |
| Contact | John G D'angelo |
| Correspondent | John G D'angelo MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 -9791 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-02 |
| Decision Date | 1991-09-06 |