510(k) K792255
K792255 is an FDA 510(k) premarket notification submitted by Keeler Optical Products , Ltd. for the device "NEVYAS AUTOPRESS EYE COMPRESSOR". The FDA issued a decision of Substantially Equivalent on December 11, 1979. The device falls under product code LCC (Applicator, Ocular Pressure), a Class II device regulated under 21 CFR 886.4610. Keeler Optical Products , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1979
- Date Received
- November 9, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ocular Pressure
- Device Class
- Class II
- Regulation Number
- 886.4610
- Review Panel
- OP
- Submission Type