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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 K861699
Device Name CATHETER VALVES KV 100 & KV 100EH
Applicant
Max Staubli , Ltd.
Spatzstrasse 14
P. O. Box Ch-8812
Horgen, Switzerland,  CH
Applicant Contact COJOCARU
Correspondent
Max Staubli , Ltd.
Spatzstrasse 14
P. O. Box Ch-8812
Horgen, Switzerland,  CH
Correspondent Contact COJOCARU
Regulation Number876.5130
Classification Product Code
KOD  
Date Received05/05/1986
Decision Date 11/19/1986
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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