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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Endoscopic, Without Audio
510(k) Number K925108
Device Name INTEGRATED VISUALIZATION SYSTEM
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 Number878.4160
Classification Product Code
FWF  
Date Received10/09/1992
Decision Date 01/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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