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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
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