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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 K180738
Device Name COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
Applicant
Compactcath, Inc.
887 Federation Way
Palo Alto,  CA  94303
Applicant Contact Naama S. Breckler
Correspondent
Atom Health Corporation
12f., #122 Songjiang Rd.
Taipei City,  TW 104
Correspondent Contact Tehyen Chu
Regulation Number876.5130
Classification Product Code
EZD  
Subsequent Product Code
EZC  
Date Received03/22/2018
Decision Date 06/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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