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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 K060563
Device Name EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
Applicant
Pajunk GmbH
Karl-Hall-Strasse 1
Geisingen,  DE D-78187
Applicant Contact CHRISTAIN QUASS
Correspondent
Pajunk GmbH
Karl-Hall-Strasse 1
Geisingen,  DE D-78187
Correspondent Contact CHRISTAIN QUASS
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received02/08/2006
Decision Date 06/02/2006
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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