MERILAS 532A

Laser, Ophthalmic

MERIDIAN AG

The following data is part of a premarket notification filed by Meridian Ag with the FDA for Merilas 532a.

Pre-market Notification Details

Device IDK072823
510k NumberK072823
Device Name:MERILAS 532A
ClassificationLaser, Ophthalmic
Applicant MERIDIAN AG 13 RED FOX LN. Littleton,  CO  80127
ContactKevin Walls
CorrespondentKevin Walls
MERIDIAN AG 13 RED FOX LN. Littleton,  CO  80127
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-02
Decision Date2007-12-14
Summary:summary

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