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510(k) K191320

Slow Wave DS8 by Slow Wave, Inc. — Product Code LQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2020
Date Received
May 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Jaw Repositioning
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances by Slow Wave, Inc.

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