The following data is part of a premarket notification filed by Mac Medical Inc. with the FDA for Mac Medical D-series Blanket And Solution Warming Cabinets.
Device ID | K180842 |
510k Number | K180842 |
Device Name: | MAC Medical D-Series Blanket And Solution Warming Cabinets |
Classification | Warmer, Thermal, Infusion Fluid |
Applicant | MAC Medical Inc. 820 S Mulberry Millstadt, IL 62260 |
Contact | Dennis Cooper |
Correspondent | Gary Oliveros MAC Medical Inc. 820 S Mulberry Millstadt, IL 62260 |
Product Code | LGZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-30 |
Decision Date | 2019-03-05 |