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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscope, neurological
510(k) Number K950154
Device Name 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES
Applicant
NEURO NAVIGATIONAL CORP.
3180 PULLMAN ST.
COSTA MESA,  CA  92626
Applicant Contact KAREN U SALINAS
Correspondent
NEURO NAVIGATIONAL CORP.
3180 PULLMAN ST.
COSTA MESA,  CA  92626
Correspondent Contact KAREN U SALINAS
Regulation Number882.1480
Classification Product Code
GWG  
Date Received01/17/1995
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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