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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophageal Sheath With Distal Balloon Anchor
510(k) Number K191078
Device Name BAROnova Access Sheath Kit
Applicant
Baronova, Inc.
1551 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact Lian Cunningham
Correspondent
Baronova, Inc.
1551 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact Lian Cunningham
Classification Product Code
QGG  
Subsequent Product Codes
FED   FMF   OCX  
Date Received04/23/2019
Decision Date 07/22/2019
Decision Substantially Equivalent - Kit (SESK)
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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