RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR
FDA 510(k) clearance K913621 · decided 1991-09-27
Clearance details
- K-number
- K913621
- Device name
- RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR
- Applicant
- Rinn Dental Products
- Decision
- Substantially Equivalent
- Date received
- 1991-08-13
- Decision date
- 1991-09-27
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- EAJ
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Elgin, IL, 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 |
|---|---|---|
| LEAD APRON (K931269) | Bt Medical Co., Inc. | 1993-06-02 |
| X-RAY APRON (K870563) | X-Tech, Ltd. | 1987-02-19 |
| LEAD APRON CADDY (K870103) | Orthopedic Systems, Inc. | 1987-01-21 |
| THYROID PROTECTIVE COLLAR (K832602) | E.M. Adams | 1983-09-29 |
| LEADED X-RAY APRON (K832601) | E.M. Adams | 1983-09-29 |
Recalls involving this device
No recalls on record reference this clearance.