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510(k) K203251

SOLOPASS System by Intravent Medical Partners, LP — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2021
Date Received
November 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Intravent Medical Partners, LP

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