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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 K931973
Device Name DISPOSABLE PEEL-AWAY INTRODUCER SHEATH
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 Received04/22/1993
Decision Date 09/14/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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