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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 K041399
Device Name HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
Applicant
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact BRIAN D FARIAS
Correspondent
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact BRIAN D FARIAS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/26/2004
Decision Date 07/28/2004
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
Recalls CDRH Recalls
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