Home / 510(k) Clearances / K180838

510(k) K180838

SaliPen by Saliwell , Ltd. — Product Code LTF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2018
Date Received
March 30, 2018
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.

  • K232063 — SaliPen (December 13, 2023)
  • K220618 — SaliPen (August 30, 2022)
  • K160799 — GenNarino (February 17, 2017)

Other clearances for product code LTF

  • K160799 — GenNarino (February 17, 2017)