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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Upper Urinary Tract
510(k) Number K041416
Device Name EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER
Applicant
DEROYAL
200 DEBUSK LN.
POWELL,  TN  37849
Applicant Contact SHARON COOK
Correspondent
DEROYAL
200 DEBUSK LN.
POWELL,  TN  37849
Correspondent Contact SHARON COOK
Regulation Number876.5130
Classification Product Code
EYC  
Date Received05/27/2004
Decision Date 07/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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