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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 K911202
Device Name ATRAUMATIC STANDARD SPROTTE NEEDLE
Applicant
PAJUNK GMBH
WASHINGTON SQUARE SUITE 1100
1050 CONNECTICUT AVENUE N.W.
WASHINGTON,  DC  20036
Applicant Contact BRUCE MACKLER
Correspondent
PAJUNK GMBH
WASHINGTON SQUARE SUITE 1100
1050 CONNECTICUT AVENUE N.W.
WASHINGTON,  DC  20036
Correspondent Contact BRUCE MACKLER
Regulation Number868.5150
Classification Product Code
BSP  
Date Received03/19/1991
Decision Date 05/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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