The following data is part of a premarket notification filed by Douglas James Donaldson Compliance Services with the FDA for Crystal Focus Emerald Laser/slt Ophf 0.6 Endo Hand.
Device ID | K905453 |
510k Number | K905453 |
Device Name: | CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND |
Classification | Laser, Ophthalmic |
Applicant | DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES 100 HEGENBERGER ROAD, SUITE 210 Oakland, CA 94621 |
Contact | Douglas Donaldson |
Correspondent | Douglas Donaldson DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES 100 HEGENBERGER ROAD, SUITE 210 Oakland, CA 94621 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-05 |
Decision Date | 1991-03-05 |