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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 K033208
Device Name IVY DEVICES INC. IV/MEDICAL LINE STABILIZER
Applicant
IVY DEVICES, INC.
P.O. BOX 23241
GRANDE PRAIRIE, ALBERTA,  CA T8V 6X2
Applicant Contact WILLIAM REILLY
Correspondent
IVY DEVICES, INC.
P.O. BOX 23241
GRANDE PRAIRIE, ALBERTA,  CA T8V 6X2
Correspondent Contact WILLIAM REILLY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/02/2003
Decision Date 03/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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