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510(k) K190143

LARS AC Band Device by Corin USA — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2019
Date Received
January 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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