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510(k) K200886

StimSite by Allotrope Medical, Inc. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2020
Date Received
April 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

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