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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K021939
Device Name VITALCARE FOLEY CATHETER
Applicant
VITALCARE, INC.
15800 NW 13TH AVE.
MIAMI,  FL  33169
Applicant Contact MICHAEL MCAVENIA
Correspondent
VITALCARE, INC.
15800 NW 13TH AVE.
MIAMI,  FL  33169
Correspondent Contact MICHAEL MCAVENIA
Regulation Number876.5130
Classification Product Code
EZL  
Date Received06/12/2002
Decision Date 04/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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