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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 K882641
Device Name TECNOL CATHETER LEG STRAP
Applicant
TECNOL NEW JERSEY WOUND CARE, INC.
7201 INDUSTRIAL PARK BLVD.
FORT WORTH,  TX  76180
Applicant Contact LEONA M HAMMEL
Correspondent
TECNOL NEW JERSEY WOUND CARE, INC.
7201 INDUSTRIAL PARK BLVD.
FORT WORTH,  TX  76180
Correspondent Contact LEONA M HAMMEL
Regulation Number876.5130
Classification Product Code
KNY  
Date Received06/27/1988
Decision Date 07/12/1988
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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