The following data is part of a premarket notification filed by Augustine Biomedical & Design, Llc with the FDA for Hotdog Multi Function Controller.
| Device ID | K094056 |
| 510k Number | K094056 |
| Device Name: | HOTDOG MULTI FUNCTION CONTROLLER |
| Classification | System, Thermal Regulating |
| Applicant | AUGUSTINE BIOMEDICAL & DESIGN, LLC 6581 CITY WEST PARKWAY Eden Prairie, MN 55344 |
| Contact | James Ecklein |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-12-31 |
| Decision Date | 2010-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00749756845878 | K094056 | 000 |
| 00749756845861 | K094056 | 000 |
| 00855913001701 | K094056 | 000 |
| 00855913001695 | K094056 | 000 |
| 00855913001640 | K094056 | 000 |
| 00855913001633 | K094056 | 000 |
| 00855913001503 | K094056 | 000 |
| 00855913001497 | K094056 | 000 |