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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K241424
Device Name InnoCare Specialty Foley Catheter
Applicant
Innocare Urologics, LLC
7175 SW 47th St., Suite 207
Miami,  FL  33155
Applicant Contact Patrick McCain
Correspondent
Innocare Urologics, LLC
7175 SW 47th St., Suite 207
Miami,  FL  33155
Correspondent Contact Patrick McCain
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
SCT  
Date Received05/20/2024
Decision Date 09/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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