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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 K953554
Device Name NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES
Applicant
NOBLES-LAI ENGINEERING, INC.
17080 NEWHOPE ST.
fountain valley,  CA  92708
Applicant Contact nancy e shadforth
Correspondent
NOBLES-LAI ENGINEERING, INC.
17080 NEWHOPE ST.
fountain valley,  CA  92708
Correspondent Contact nancy e shadforth
Regulation Number882.1480
Classification Product Code
GWG  
Date Received07/28/1995
Decision Date 10/18/1995
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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