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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K000722
Device Name UNIPOLAR NEEDLES
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 Number868.5150
Classification Product Code
BSP  
Date Received03/03/2000
Decision Date 03/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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