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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 K031748
Device Name VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
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 Number876.5130
Classification Product Code
EZL  
Date Received06/05/2003
Decision Date 08/27/2003
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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