K110900 is an FDA 510(k) clearance for the DISPOSABLE THYROID COLLAR. This device is classified as a Shield, Protective, Personnel (Class I - General Controls, product code KPY).
Submitted by Bloxr Corporation (Salt Lake City, US). The FDA issued a Cleared decision on June 24, 2011, 85 days after receiving the submission on March 31, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.
| 510(k) Number | K110900 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2011 |
| Decision Date | June 24, 2011 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPY — Shield, Protective, Personnel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.6500 |