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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 K011925
Device Name HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
Applicant
Sims Portex, Inc.
10 Bowman Dr.
Keene,  NH  03431
Applicant Contact BRAIN D FARIAS
Correspondent
Sims Portex, Inc.
10 Bowman Dr.
Keene,  NH  03431
Correspondent Contact BRAIN D FARIAS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/20/2001
Decision Date 07/12/2001
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
Recalls CDRH Recalls
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