The following data is part of a premarket notification filed by Bloxr Corporation with the FDA for Disposable Thyroid Collar.
Device ID | K110900 |
510k Number | K110900 |
Device Name: | DISPOSABLE THYROID COLLAR |
Classification | Shield, Protective, Personnel |
Applicant | BLOXR CORPORATION 2116 LAKE CITY Salt Lake City, UT 84109 |
Contact | Rai Chowdhary |
Correspondent | Rai Chowdhary BLOXR CORPORATION 2116 LAKE CITY Salt Lake City, UT 84109 |
Product Code | KPY |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-31 |
Decision Date | 2011-06-24 |
Summary: | summary |