510(k) K833523
K833523 is an FDA 510(k) premarket notification submitted by Radiology Design for the device "C.B. RADIOLOGY DESIGN GONADSHIELD". The FDA issued a decision of Substantially Equivalent on November 21, 1983. The device falls under product code IWT (Shield, Gonadal), a Class I device regulated under 21 CFR 892.6500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1983
- Date Received
- September 20, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shield, Gonadal
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type