510(k) K833523
- Device
- C.b. Radiology Design Gonadshield
- Applicant
- RADIOLOGY DESIGN
- 510(k) number
- K833523
- Product code
- IWT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-21
- Date received
- 1983-09-20
- Regulation
- 892.6500
- Classification name
- Shield, Gonadal
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2431224
- 2182762
- 1225473
- 3007069733
- 9680506
- 3020118
- 3005908723
- 1053541
- 1222742
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IWT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930763 | FIGLEAF SHIELD | Byers Industries, Inc. | 1993-05-17 |