The following data is part of a premarket notification filed by Stryker Medical with the FDA for Altrix Temperature Management Wraps.
| Device ID | K171149 |
| 510k Number | K171149 |
| Device Name: | Altrix Temperature Management Wraps |
| Classification | System, Thermal Regulating |
| Applicant | Stryker Medical 3800 East Centre Avenue Portage, MI 49002 |
| Contact | Brian Orwat |
| Correspondent | Brian Orwat Stryker Medical 3800 East Centre Avenue Portage, MI 49002 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-19 |
| Decision Date | 2017-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 57613327374310 | K171149 | 000 |
| 57613327374143 | K171149 | 000 |
| 57613327374136 | K171149 | 000 |
| 57613327374129 | K171149 | 000 |
| 57613327374112 | K171149 | 000 |
| 57613327374105 | K171149 | 000 |
| 57613327374099 | K171149 | 000 |
| 57613327374082 | K171149 | 000 |
| 57613327374327 | K171149 | 000 |
| 57613327374150 | K171149 | 000 |
| 57613327374167 | K171149 | 000 |
| 57613327374303 | K171149 | 000 |
| 57613327374297 | K171149 | 000 |
| 57613327374280 | K171149 | 000 |
| 57613327374273 | K171149 | 000 |
| 57613327374266 | K171149 | 000 |
| 57613327374259 | K171149 | 000 |
| 57613327374235 | K171149 | 000 |
| 57613327374174 | K171149 | 000 |
| 57613327374242 | K171149 | 000 |