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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 K934072
Device Name CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
Applicant
Contour Fabricators of Florida, Inc.
3340 Scherer Dr.
St. Petersburg,  FL  33716
Applicant Contact SCOTT WILLAIMS
Correspondent
Contour Fabricators of Florida, Inc.
3340 Scherer Dr.
St. Petersburg,  FL  33716
Correspondent Contact SCOTT WILLAIMS
Regulation Number876.5130
Classification Product Code
KNY  
Subsequent Product Code
KNT  
Date Received08/20/1993
Decision Date 09/08/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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