The following data is part of a premarket notification filed by Augustine Biomedical & Design, Llc with the FDA for Hot Dog Patient Warming System.
| Device ID | K052392 |
| 510k Number | K052392 |
| Device Name: | HOT DOG PATIENT WARMING SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | AUGUSTINE BIOMEDICAL & DESIGN, LLC 6581 CITY WEST PARKWAY Eden Prairie, MN 55344 |
| Contact | James D Ecklein |
| Correspondent | James D Ecklein AUGUSTINE BIOMEDICAL & DESIGN, LLC 6581 CITY WEST PARKWAY Eden Prairie, MN 55344 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-31 |
| Decision Date | 2006-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00749756845885 | K052392 | 000 |
| 00855913001626 | K052392 | 000 |
| 00855913001619 | K052392 | 000 |
| 00855913001480 | K052392 | 000 |
| 00855913001398 | K052392 | 000 |
| 00855913001381 | K052392 | 000 |
| 00855913001268 | K052392 | 000 |
| 00855913001251 | K052392 | 000 |
| 00855913001107 | K052392 | 000 |
| 00855913001671 | K052392 | 000 |
| 00855913001688 | K052392 | 000 |
| 00749756845830 | K052392 | 000 |
| 00749756845823 | K052392 | 000 |
| 00749756845816 | K052392 | 000 |
| 00749756845762 | K052392 | 000 |
| 00749756845755 | K052392 | 000 |
| 00749756845632 | K052392 | 000 |
| 00855913001961 | K052392 | 000 |
| 00855913001893 | K052392 | 000 |
| 00855913001015 | K052392 | 000 |