510(k) K924782
K924782 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "BURTON SLIT LAMP - MODEL 2000". The FDA issued a decision of Substantially Equivalent on January 27, 1993. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. R.H. Burton Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1993
- Date Received
- September 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type