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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 K090262
Device Name PERCUCATH URINARY CATHETER
Applicant
Percuvision, LLC
765 N. Hamilton Rd.
Suite 260a
Gahanna,  OH  43230
Applicant Contact ERROL SINGH
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number876.5130
Classification Product Code
EZL  
Date Received02/03/2009
Decision Date 05/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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