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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 K043130
Device Name MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
Applicant
Pajunk GmbH
5101 NW Crescent Valley Dr.
Corvallis,  OR  97330
Applicant Contact BURK A BRANDT
Correspondent
Pajunk GmbH
5101 NW Crescent Valley Dr.
Corvallis,  OR  97330
Correspondent Contact BURK A BRANDT
Regulation Number868.5140
Classification Product Code
CAZ  
Subsequent Product Code
BSP  
Date Received11/12/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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