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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 K160294
Device Name SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
Applicant
PAJUNK GmbH Medizintechnologie
Karl-Hall St. 1
Geisingen,  DE 78187
Applicant Contact CHRISTIAN G.H. QUASS
Correspondent
PAJUNK GmbH Medizintechnologie
Karl-Hall St. 1
Geisingen,  DE 78187
Correspondent Contact CHRISTIAN G.H. QUASS
Regulation Number868.5150
Classification Product Code
BSP  
Date Received02/03/2016
Decision Date 10/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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