DISPOSABLE OPTICAL VALVULOTOME

Valvulotome

NOBLES-LAI ENGINEERING, INC.

The following data is part of a premarket notification filed by Nobles-lai Engineering, Inc. with the FDA for Disposable Optical Valvulotome.

Pre-market Notification Details

Device IDK914457
510k NumberK914457
Device Name:DISPOSABLE OPTICAL VALVULOTOME
ClassificationValvulotome
Applicant NOBLES-LAI ENGINEERING, INC. 3178 PULLMAN ST. Costa Mesa,  CA  92626
ContactKaren U Salinas
CorrespondentKaren U Salinas
NOBLES-LAI ENGINEERING, INC. 3178 PULLMAN ST. Costa Mesa,  CA  92626
Product CodeMGZ  
CFR Regulation Number870.4885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-07
Decision Date1992-02-05

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