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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K011120
Device Name GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES
Applicant
NIPRO DIABETES SYSTEMS, INC.
1384 COPPERFIELD COURT
LEXINGTON,  KY  40514
Applicant Contact KAELYN B HADLEY
Correspondent
NIPRO DIABETES SYSTEMS, INC.
1384 COPPERFIELD COURT
LEXINGTON,  KY  40514
Correspondent Contact KAELYN B HADLEY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/12/2001
Decision Date 05/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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