510(k) K930763
- Device
- FIGLEAF SHIELD
- Applicant
- BYERS INDUSTRIES, INC.
- 510(k) number
- K930763
- Product code
- IWT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-05-17
- Date received
- 1993-02-12
- Regulation
- 892.6500
- Classification name
- Shield, Gonadal
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES J STORM
- Address
- 6955 SW Sandburg St. Portland OR US 97223 97223
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 |
|---|---|---|---|
| K833523 | C.B. RADIOLOGY DESIGN GONADSHIELD | Radiology Design | 1983-11-21 |
Legacy Summary#
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FDA Review#
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