The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Modified Volumetric Infusion Pump.
Device ID | K913661 |
510k Number | K913661 |
Device Name: | MODIFIED VOLUMETRIC INFUSION PUMP |
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 | 1991-08-02 |
Decision Date | 1991-12-18 |