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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, straight
510(k) Number K220667
Device Name Sleeved IC
Applicant
Hollister Incorporated
2000 Hollister Drive
Libertyville,  IL  60048
Applicant Contact Sandra Mullen
Correspondent
Hollister Incorporated
2000 Hollister Drive
Libertyville,  IL  60048
Correspondent Contact Sandra Mullen
Regulation Number876.5130
Classification Product Code
EZD  
Date Received03/07/2022
Decision Date 12/08/2022
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
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