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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K172575
Device Name BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
Applicant
BAROnova, Inc.
1509 Industrial Road
San Carlos,  CA  94070
Applicant Contact Lian Cunningham
Correspondent
BAROnova, Inc.
1509 Industrial Road
San Carlos,  CA  94070
Correspondent Contact Lian Cunningham
Regulation Number876.1500
Classification Product Code
FED  
Subsequent Product Code
OCX  
Date Received08/28/2017
Decision Date 01/18/2018
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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