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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K232571
Device Name CATHTONG™ II PICC Catheter
Applicant
L&Z US, Inc.
49 Walnut Street
Unit 1
Norwood,  NJ  07648
Applicant Contact James Li
Correspondent
L&Z US, Inc.
49 Walnut Street
Unit 1
Norwood,  NJ  07648
Correspondent Contact James Li
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/24/2023
Decision Date 09/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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