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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 K113188
Device Name SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
Applicant
Pajunk GmbH Medizintechnologie
Karl-Hall-Strasse 1
Geisingen,  DE 78187
Applicant Contact CHRISTIAN G QUASS
Correspondent
Pajunk GmbH Medizintechnologie
Karl-Hall-Strasse 1
Geisingen,  DE 78187
Correspondent Contact CHRISTIAN G QUASS
Regulation Number868.5140
Classification Product Code
CAZ  
Subsequent Product Codes
BSO   BSP  
Date Received10/31/2011
Decision Date 03/01/2012
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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