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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 K842890
Device Name PERCUFIX CATHETER CUFF
Applicant
Medi-Tech, Inc.
P.O. Box 7407
Watertown,  MA  02272
Applicant Contact SAMUEL D WADE
Correspondent
Medi-Tech, Inc.
P.O. Box 7407
Watertown,  MA  02272
Correspondent Contact SAMUEL D WADE
Regulation Number876.5130
Classification Product Code
KOD  
Date Received07/23/1984
Decision Date 09/04/1984
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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