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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, urethral
510(k) Number K191633
Device Name Infyna Chic
Applicant
Hollister Incorporated
2000 Hollister Drive
libertyville,  IL  60048
Applicant Contact michelle schiltz-taing
Correspondent
Hollister Incorporated
2000 Hollister Drive
libertyville,  IL  60048
Correspondent Contact michelle schiltz-taing
Regulation Number876.5130
Classification Product Code
GBM  
Date Received06/19/2019
Decision Date 07/19/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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