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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastrointestinal tubes with enteral specific connectors
510(k) Number K200082
Device Name BD Univia RightFit Enteral Extension Sets and Transitional Adapters
Applicant
MPS Medical, Inc.
830 Challenger Street, Suite 200
Brea,  CA  92821
Applicant Contact Barry Kazemi
Correspondent
MPS Medical, Inc.
830 Challenger Street, Suite 200
Brea,  CA  92821
Correspondent Contact Paul Gasser
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
PIO  
Date Received01/15/2020
Decision Date 07/30/2020
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
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