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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 K993568
Device Name MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
Applicant
Machida Endoscope Co., Ltd.
13-8, Honkomagome 6-Chome,
Bunkyo-Ku
Tokyo,  JP
Applicant Contact GENICHI KANAI
Correspondent
Machida Endoscope Co., Ltd.
13-8, Honkomagome 6-Chome,
Bunkyo-Ku
Tokyo,  JP
Correspondent Contact GENICHI KANAI
Regulation Number882.1480
Classification Product Code
GWG  
Date Received10/21/1999
Decision Date 03/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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