510(k) K834060
K834060 is an FDA 510(k) premarket notification submitted by F. & F. Koenigkramer for the device "RELIANCE OPHTHALMIC SLIT LAMP R-083". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. F. & F. Koenigkramer has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1984
- Date Received
- November 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type