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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 K160296
Device Name SPROTTE SPECIAL NRFit
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  
Date Received02/03/2016
Decision Date 10/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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