O.M.S. ULTRA-PHACO

Unit, Phacofragmentation

OPTICAL MICRO SYSTEMS, INC.

The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for O.m.s. Ultra-phaco.

Pre-market Notification Details

Device IDK844373
510k NumberK844373
Device Name:O.M.S. ULTRA-PHACO
ClassificationUnit, Phacofragmentation
Applicant OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers,  MA  01923
ContactGerald A Clay
CorrespondentGerald A Clay
OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers,  MA  01923
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-13
Decision Date1985-12-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.