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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 K050906
Device Name VITALCARE I.V. ADMINISTRATION SET
Applicant
Vitalcare Group, Inc.
8935 NW 27th St.
Miami,  FL  33172
Applicant Contact MICHAEL MCAVENIA
Correspondent
Vitalcare Group, Inc.
8935 NW 27th St.
Miami,  FL  33172
Correspondent Contact MICHAEL MCAVENIA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/11/2005
Decision Date 08/23/2005
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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