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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 K040965
Device Name PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
Applicant
PAJUNK GMBH
203 MAIN STREET, PMB 166
FLEMINGTON,,  NJ  08822
Applicant Contact LYNETTE HOWARD
Correspondent
PAJUNK GMBH
203 MAIN STREET, PMB 166
FLEMINGTON,,  NJ  08822
Correspondent Contact LYNETTE HOWARD
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/14/2004
Decision Date 09/07/2004
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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