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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name anesthesia conduction kit
510(k) Number K202699
Device Name E-Cath STIM acc. Tsui
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 Number868.5140
Classification Product Code
CAZ  
Subsequent Product Codes
BSO   BSP  
Date Received09/16/2020
Decision Date 12/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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