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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 K052474
Device Name NIPRO HYPODERMIC NEEDLE
Applicant
NIPRO MEDICAL CORP.
1384 COPPERFIELD COURT
LEXINGTON,  KY  40514 -1268
Applicant Contact KAELYN B HADLEY
Correspondent
NIPRO MEDICAL CORP.
1384 COPPERFIELD COURT
LEXINGTON,  KY  40514 -1268
Correspondent Contact KAELYN B HADLEY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/09/2005
Decision Date 11/10/2005
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
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