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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 K260502
Device Name Liv Pre-lubricated Intermittent Catheter
Applicant
HR Healthcare
2600 Eastern Blvd., Suite 201
York,  PA  17402
Applicant Contact Colby Wiesman
Correspondent
Third Party Review Group, LLC
7 Giralda Farms, Suite 120a
Madison,  NJ  07940
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.5130
Classification Product Code
EZD  
Date Received02/13/2026
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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