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FDA 510(k) Application Details - K222085
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K222085
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
Standard Bariatrics, Inc.
4362 Glendale Milford Road
Cincinnati, OH 45242 US
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Contact
Michelle Schnell
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
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More FDA Info for this Product Code
Date Received
07/15/2022
Decision Date
10/31/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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