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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K170435
Device Name NerveGuard NRFit, NerveGuard LUER
Applicant
PAJUNK GmbH Medizintechnologie
Karl-Hall-Str. 1
Geisingen,  DE 78187
Applicant Contact Christian G.H. Quass
Correspondent
PAJUNK GmbH Medizintechnologie
Karl-Hall-Str. 1
Geisingen,  DE 78187
Correspondent Contact Christian G.H. Quass
Regulation Number868.5150
Classification Product Code
BSP  
Subsequent Product Code
CAZ  
Date Received02/13/2017
Decision Date 07/12/2017
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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