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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K912146
Device Name URETERAL CATHETER HOLDER
Applicant
Inman Liebelt Corp.
P.O. Box 171077
Arlington,  TX  76003
Applicant Contact CLAY WILSON
Correspondent
Inman Liebelt Corp.
P.O. Box 171077
Arlington,  TX  76003
Correspondent Contact CLAY WILSON
Regulation Number876.5130
Classification Product Code
KNY  
Date Received05/15/1991
Decision Date 07/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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