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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 K113207
Device Name SONO TAP, TUOHY SONO
Applicant
PAJUNK GMBH
KARL-HALL-STRASSE 1
GEISINGEN,  DE D-78187
Applicant Contact CHRISTIAN QUASS
Correspondent
PAJUNK GMBH
KARL-HALL-STRASSE 1
GEISINGEN,  DE D-78187
Correspondent Contact CHRISTIAN QUASS
Regulation Number868.5150
Classification Product Code
BSP  
Date Received10/31/2011
Decision Date 02/29/2012
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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