510(k) K924784
K924784 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "BURTON PROJECTOR HEAD - MODEL 6000-H". The FDA issued a decision of Substantially Equivalent on April 5, 1993. The device falls under product code HOS (Projector, Ophthalmic), a Class I device regulated under 21 CFR 886.1680. R.H. Burton Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1993
- Date Received
- September 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Projector, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1680
- Review Panel
- OP
- Submission Type