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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K060268
Device Name PEDIATRIC URINARY CATHETER
Applicant
Clay Kennard
2909 Browne Stone Rd.
Oklahoma City,  OK  73120
Applicant Contact CLAY KENNARD
Correspondent
Clay Kennard
2909 Browne Stone Rd.
Oklahoma City,  OK  73120
Correspondent Contact CLAY KENNARD
Regulation Number876.5130
Classification Product Code
GBM  
Date Received02/01/2006
Decision Date 02/24/2006
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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