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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K040527
Device Name LOW PROFILE LUTHER SAFETY HUBER
Applicant
LUTHER NEEDLESAFE PRODUCTS, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
LUTHER NEEDLESAFE PRODUCTS, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/01/2004
Decision Date 03/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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