2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE

Arthroscope

NEURO NAVIGATIONAL CORP.

The following data is part of a premarket notification filed by Neuro Navigational Corp. with the FDA for 2.3 Mm Disposable Neuroview Endoscope.

Pre-market Notification Details

Device IDK940483
510k NumberK940483
Device Name:2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE
ClassificationArthroscope
Applicant NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa,  CA  92626
ContactKaren U Salinas
CorrespondentKaren U Salinas
NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa,  CA  92626
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-02
Decision Date1995-05-02

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