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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name retractor, self-retaining, for neurosurgery
510(k) Number K202072
Device Name MindsEye Expandable Port
Applicant
Minnetronix Neuro, INC.
1635 Energy Park Drive
st. paul,  MN  55108
Applicant Contact matt adams
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact prithul bom
Regulation Number882.4800
Classification Product Code
GZT  
Date Received07/27/2020
Decision Date 08/26/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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