DISPOSABLE ASPIRATION/IRRIGATION CATHETER

Endoscope, Neurological

NEURO NAVIGATIONAL CORP.

The following data is part of a premarket notification filed by Neuro Navigational Corp. with the FDA for Disposable Aspiration/irrigation Catheter.

Pre-market Notification Details

Device IDK934154
510k NumberK934154
Device Name:DISPOSABLE ASPIRATION/IRRIGATION CATHETER
ClassificationEndoscope, Neurological
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 CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-27
Decision Date1995-02-21

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