MICRORUPTER V

Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

MERIDIAN AG

The following data is part of a premarket notification filed by Meridian Ag with the FDA for Microrupter V.

Pre-market Notification Details

Device IDK023045
510k NumberK023045
Device Name:MICRORUPTER V
ClassificationLaser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Applicant MERIDIAN AG BIERIGUTSTRASSE 7 Thun, Bern,  CH 3608
ContactKurt Frey
CorrespondentMark Job
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeLXS  
CFR Regulation Number886.4392 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2002-09-12
Decision Date2002-09-26
Summary:summary

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