Cleared Traditional

PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND

K030813 · Primary Care Solutions, Inc. · Gastroenterology & Urology

May 2003

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K030813 is an FDA 510(k) clearance for the PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Primary Care Solutions, Inc. (Zephyrhills, US). The FDA issued a Cleared decision on May 30, 2003, 77 days after receiving the submission on March 14, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K030813 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2003
Decision Date	May 30, 2003
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF