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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, antistick
510(k) Number K063755
Device Name PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
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 Number880.5860
Classification Product Code
MEG  
Date Received12/19/2006
Decision Date 02/27/2007
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
Recalls CDRH Recalls
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