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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K041158
Device Name ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
Applicant
ATRION MEDICAL PRODUCTS, INC.
1426 CURT FRANCIS RD.
ARAB,  AL  35016
Applicant Contact DAN CLARK
Correspondent
ATRION MEDICAL PRODUCTS, INC.
1426 CURT FRANCIS RD.
ARAB,  AL  35016
Correspondent Contact DAN CLARK
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/03/2004
Decision Date 06/16/2004
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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