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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 K896729
Device Name NELATON-, FEMALE - OR TIEMANN CATHETER
Applicant
Unoplast A/S
Dk-3390 Hundested
Denmark,  DK
Applicant Contact ERIK ANDERSEN
Correspondent
Unoplast A/S
Dk-3390 Hundested
Denmark,  DK
Correspondent Contact ERIK ANDERSEN
Regulation Number876.5130
Classification Product Code
KOD  
Date Received11/30/1989
Decision Date 11/05/1990
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
Recalls CDRH Recalls
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