FDA 510(k) Application Details - K212728

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K212728
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	08/27/2021
Decision Date	09/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review