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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K043249
Device Name ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
Applicant
Atrion Medical Products, Inc.
1426 Curt Francis Rd.
P.O. Box 564
Arab,  AL  35016
Applicant Contact DAN CLARK
Correspondent
Atrion Medical Products, Inc.
1426 Curt Francis Rd.
P.O. Box 564
Arab,  AL  35016
Correspondent Contact DAN CLARK
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/23/2004
Decision Date 05/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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