DISPOSABLE THYROID COLLAR
FDA 510(k) clearance K110900 · decided 2011-06-24
Clearance details
- K-number
- K110900
- Device name
- DISPOSABLE THYROID COLLAR
- Applicant
- Bloxr Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-03-31
- Decision date
- 2011-06-24
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- KPY
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INTRA-ORAL THERMOPLASTIC SHIELD (K962622) | Medtec, Inc. | 1996-10-01 |
| THERMOPLASTIC SHIELD (K954456) | Medtec, Inc. | 1995-12-21 |
| UTK-DTE AUTILARY SHIELD (K954146) | Mallinckrodt Medical | 1995-12-06 |
| AUKULYTE (K953610) | Aukland Medical Plastics, Inc. | 1995-09-26 |
| 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (K951004) | Kenex , Ltd. | 1995-04-10 |
| KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (K951003) | Kenex , Ltd. | 1995-04-03 |
| STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (K940539) | Standard Imaging, Inc. | 1994-03-16 |
| MAVIG ANGIO SHIELD MODELS 6290 & 6272 (K934206) | F. Walter Hanel GmbH | 1993-10-07 |
| DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (K912326) | Davis Lead Aprons, Inc. | 1992-03-18 |
| DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. (K912327) | Davis Lead Aprons, Inc. | 1992-03-18 |
| DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS (K912378) | Davis Lead Aprons, Inc. | 1992-03-18 |
| RADIATION PROTECTION GLASSES (K900970) | Infab Corp. | 1990-05-01 |
Recalls involving this device
No recalls on record reference this clearance.