510(k) K924774
K924774 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "BURTON AUTOMATIC PROJECTOR - MODEL CP-40". The FDA issued a decision of Substantially Equivalent on April 14, 1993. The device falls under product code HOD (Clamp, Eyelid, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. R.H. Burton Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1993
- Date Received
- September 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Eyelid, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type