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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 K983411
Device Name COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105
Applicant
Valnet Medical Corp.
B St., Felicia Industrial Park
(Playa) Lot #16
Santa Isabel,  PR  00757 -0859
Applicant Contact VICTOR M ORTIZ MEDINA
Correspondent
Valnet Medical Corp.
B St., Felicia Industrial Park
(Playa) Lot #16
Santa Isabel,  PR  00757 -0859
Correspondent Contact VICTOR M ORTIZ MEDINA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/28/1998
Decision Date 02/09/1999
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
Predetermined Change
Control Plan Authorized		 No
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