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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 K013041
Device Name PLEXOLONG SETS
Applicant
Pajunk GmbH
5010 NW Crescent Valley Dr.
Corvallis,  OR  97330
Applicant Contact BURK A BRANDT
Correspondent
Pajunk GmbH
5010 NW Crescent Valley Dr.
Corvallis,  OR  97330
Correspondent Contact BURK A BRANDT
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received09/10/2001
Decision Date 06/11/2002
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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