510(k) K791923
K791923 is an FDA 510(k) premarket notification submitted by Ocularists , Ltd. for the device "SCLERAL POWDER". The FDA issued a decision of Substantially Equivalent on January 10, 1980. The device falls under product code HQH (Eye, Artificial, Non-Custom), a Class I device regulated under 21 CFR 886.3200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1980
- Date Received
- September 26, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eye, Artificial, Non-Custom
- Device Class
- Class I
- Regulation Number
- 886.3200
- Review Panel
- OP
- Submission Type