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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K060643
Device Name QL LOCKING SYRINGE
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 Number870.1650
Classification Product Code
MAV  
Date Received03/10/2006
Decision Date 07/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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