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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 K063450
Device Name PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
Applicant
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact BRIAN FARIAS
Correspondent
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact BRIAN FARIAS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/15/2006
Decision Date 01/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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