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 |