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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 K181445
Device Name AMSure Hydrophilic Intermittent Catheter
Applicant
Amsino International, Inc.
708 Corporate Center Dr.
Pomona,  CA  91768
Applicant Contact Zoe Wu
Correspondent
Amsino International, Inc.
708 Corporate Center Dr.
Pomona,  CA  91768
Correspondent Contact Zoe Wu
Regulation Number876.5130
Classification Product Code
EZD  
Date Received06/01/2018
Decision Date 10/01/2018
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
Predetermined Change
Control Plan Authorized		 No
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