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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 K153469
Device Name Cathtong I PICC Catheter
Applicant
L&Z Us, Inc.
6 Horizon Rd., #2301
Fort Lee,  NJ  07024
Applicant Contact JENELLA COUTTS
Correspondent
L&Z Us, Inc.
6 Horizon Rd., #2301
Fort Lee,  NJ  07024
Correspondent Contact JENELLA COUTTS
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/01/2015
Decision Date 09/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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