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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 K991989
Device Name MITAKA POINT SETTER
Applicant
Mitaka USA, Inc.
2337 Lucky John Dr.
Park City,  UT  84060
Applicant Contact MAX STURGIS
Correspondent
Mitaka USA, Inc.
2337 Lucky John Dr.
Park City,  UT  84060
Correspondent Contact MAX STURGIS
Regulation Number882.1480
Classification Product Code
GWG  
Date Received06/14/1999
Decision Date 08/27/1999
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
Recalls CDRH Recalls
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