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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K861200
Device Name UROTOPO CATHETER
Applicant
Houston Biomedical, Inc.
1900 Yorktown Suite 400
Houston,  TX  77056
Applicant Contact DAVID P SUMMERS
Correspondent
Houston Biomedical, Inc.
1900 Yorktown Suite 400
Houston,  TX  77056
Correspondent Contact DAVID P SUMMERS
Regulation Number876.5130
Classification Product Code
KOD  
Date Received03/31/1986
Decision Date 04/23/1986
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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