510(k) K934459
K934459 is an FDA 510(k) premarket notification submitted by Med-Genesis, Inc. for the device "MED-GENESIS PATIENT LASER EYE SHIELD". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code IWS (Shield, Eye, Radiological), a Class I device regulated under 21 CFR 892.6500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1994
- Date Received
- September 10, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shield, Eye, Radiological
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type