CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND

Laser, Ophthalmic

DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES

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.

Pre-market Notification Details

Device IDK905453
510k NumberK905453
Device Name:CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND
ClassificationLaser, Ophthalmic
Applicant DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES 100 HEGENBERGER ROAD, SUITE 210 Oakland,  CA  94621
ContactDouglas Donaldson
CorrespondentDouglas Donaldson
DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES 100 HEGENBERGER ROAD, SUITE 210 Oakland,  CA  94621
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-05
Decision Date1991-03-05

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