The following data is part of a premarket notification filed by Augustine Temperature Management with the FDA for Hotdog Temperature Management System.
Device ID | K220941 |
510k Number | K220941 |
Device Name: | HotDog Temperature Management System |
Classification | System, Thermal Regulating |
Applicant | Augustine Temperature Management 7656 West 78th Street Minneapolis, MN 55439 |
Contact | Garrett Augustine |
Correspondent | Garrett Augustine Augustine Temperature Management 7656 West 78th Street Minneapolis, MN 55439 |
Product Code | DWJ |
CFR Regulation Number | 870.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-31 |
Decision Date | 2022-09-23 |