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510(k) K191701

Arcus Head Fixation Frame by Mri Interventions, Inc. — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2019
Date Received
June 25, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Neurosurgical (Skull Clamp)
Device Class
Class II
Regulation Number
882.4460
Review Panel
NE
Submission Type

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