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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 K021530
Device Name SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
Applicant
STERLING MEDIVATIONS, INC.
66 NEPTUNE DR.
GROTON,  CT  06340
Applicant Contact JOEL DOUGLAS
Correspondent
STERLING MEDIVATIONS, INC.
66 NEPTUNE DR.
GROTON,  CT  06340
Correspondent Contact JOEL DOUGLAS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/10/2002
Decision Date 05/21/2002
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
Predetermined Change
Control Plan Authorized		 No
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