The following data is part of a premarket notification filed by Covidien with the FDA for Warmtouch Surgical Access Blanket, Warmtouch Torso Blanket.
| Device ID | K131361 |
| 510k Number | K131361 |
| Device Name: | WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET |
| Classification | System, Thermal Regulating |
| Applicant | COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Contact | Stacey A Strand |
| Correspondent | Stacey A Strand COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-13 |
| Decision Date | 2013-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521141114 | K131361 | 000 |
| 20884521141121 | K131361 | 000 |