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FDA 510(k) Application Details - K210437
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K210437
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
Standard Bariatrics
4362 Glendale Milford Rd.
Cincinnati, OH 45242 US
Other 510(k) Applications for this Company
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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/2021
Decision Date
06/29/2021
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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