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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K014073
Device Name HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
Applicant
Portex, Inc.
10 Bowman Dr.
Keene,  NH  03431
Applicant Contact BRAIN E FARIAS
Correspondent
Portex, Inc.
10 Bowman Dr.
Keene,  NH  03431
Correspondent Contact BRAIN E FARIAS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/10/2001
Decision Date 02/13/2002
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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