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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 K030813
FOIA Releasable 510(k) K030813
Device Name PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
Applicant
Primary Care Solutions, Inc.
40420 Free Fall Ave.
Zephyrhills,  FL  33540
Applicant Contact RON MADDIX
Correspondent
Primary Care Solutions, Inc.
40420 Free Fall Ave.
Zephyrhills,  FL  33540
Correspondent Contact RON MADDIX
Regulation Number876.5130
Classification Product Code
EZL  
Date Received03/14/2003
Decision Date 05/30/2003
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
Recalls CDRH Recalls
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