C.B. RADIOLOGY DESIGN GONADSHIELD
FDA 510(k) clearance K833523 · decided 1983-11-21
Clearance details
- K-number
- K833523
- Device name
- C.B. RADIOLOGY DESIGN GONADSHIELD
- Applicant
- Radiology Design
- Decision
- Substantially Equivalent
- Date received
- 1983-09-20
- Decision date
- 1983-11-21
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- IWT
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, 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 |
|---|---|---|
| FIGLEAF SHIELD (K930763) | Byers Industries, Inc. | 1993-05-17 |
Recalls involving this device
No recalls on record reference this clearance.