510(k) K782141
K782141 is an FDA 510(k) premarket notification submitted by Keeler Optical Products , Ltd. for the device "LEVIGATOR, KEELER PHOKO". The FDA issued a decision of Substantially Equivalent on January 26, 1979. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Keeler Optical Products , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1979
- Date Received
- December 27, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type