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510(k) K202072

MindsEye Expandable Port by Minnetronix Neuro, Inc. — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2020
Date Received
July 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

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