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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 K010341
Device Name MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
Applicant
Medtronic PS Medical
125 Cremona Dr.
Goleta,  CA  93117
Applicant Contact JANET MCAULEY
Correspondent
Medtronic PS Medical
125 Cremona Dr.
Goleta,  CA  93117
Correspondent Contact JANET MCAULEY
Regulation Number882.1480
Classification Product Code
GWG  
Date Received02/05/2001
Decision Date 04/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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