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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 K021296
Device Name SIMPLICITY QD EASY P INFUSION SET
Applicant
STERLING MEDIVATIONS, INC.
66 NEPTUNE DR.
GROTON,  CT  06340
Applicant Contact JOEL S DOUGLAS
Correspondent
STERLING MEDIVATIONS, INC.
66 NEPTUNE DR.
GROTON,  CT  06340
Correspondent Contact JOEL S DOUGLAS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/24/2002
Decision Date 05/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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