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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 K911260
Device Name ATRAUMATIC STANDARD SPROTTE NEEDLE
Applicant
PAJUNK GMBH
WASHINGTON SQUARE SUITE 1100
1050 CONNECTICUT AVENUE N.W.
WASHINGTON,  DC  20036
Applicant Contact BRUCE F MACKLER
Correspondent
PAJUNK GMBH
WASHINGTON SQUARE SUITE 1100
1050 CONNECTICUT AVENUE N.W.
WASHINGTON,  DC  20036
Correspondent Contact BRUCE F MACKLER
Regulation Number868.5150
Classification Product Code
BSP  
Date Received03/22/1991
Decision Date 10/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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