DISPOSABLE N-PE MICROKERATOME BLADES

Keratome, Ac-powered

OASIS MEDICAL, INC.

The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Disposable N-pe Microkeratome Blades.

Pre-market Notification Details

Device IDK022205
510k NumberK022205
Device Name:DISPOSABLE N-PE MICROKERATOME BLADES
ClassificationKeratome, Ac-powered
Applicant OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. Glendora,  CA  91741
ContactYvonne Fernandez
CorrespondentYvonne Fernandez
OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. Glendora,  CA  91741
Product CodeHNO  
CFR Regulation Number886.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-05
Decision Date2002-10-03
Summary:summary

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