The following data is part of a premarket notification filed by Augustine Temperature Management with the FDA for Hotdog Temperature Management Controller.
| Device ID | K201779 |
| 510k Number | K201779 |
| Device Name: | HotDog Temperature Management Controller |
| Classification | System, Thermal Regulating |
| Applicant | Augustine Temperature Management 7656 West 78th Street Minneapolis, MN 55439 |
| Contact | Temi Ogunse |
| Correspondent | Temi Ogunse Augustine Temperature Management 7656 West 78th Street Minneapolis, MN 55439 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2020-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011479582 | K201779 | 000 |
| 00850011479025 | K201779 | 000 |
| 00850011479018 | K201779 | 000 |