The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Barrier Easywarm Active Self-warming Blanket.
| Device ID | K132048 |
| 510k Number | K132048 |
| Device Name: | BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET |
| Classification | System, Thermal Regulating |
| Applicant | MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Curtis D Truesdale |
| Correspondent | Curtis D Truesdale MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-02 |
| Decision Date | 2013-11-06 |
| Summary: | summary |