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510(k) K160799

GenNarino by Saliwell , Ltd. — Product Code LTF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2017
Date Received
March 23, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Salivary System
Device Class
Class II
Regulation Number
872.5560
Review Panel
DE
Submission Type

Other clearances by Saliwell , Ltd.

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Other clearances for product code LTF

  • K180838 — SaliPen (November 6, 2018)