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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K162086
Device Name MultiStim ECO
Applicant
PAJUNK GmbH Medizintechnologie
Karl-Hall-Str. 1
Geisingen,  DE 78187
Applicant Contact Christian Quass
Correspondent
PAJUNK GmbH Medizintechnologie
Karl-Hall-Str. 1
Geisingen,  DE 78187
Correspondent Contact Christian Quass
Regulation Number868.2775
Classification Product Code
BXN  
Date Received07/27/2016
Decision Date 01/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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