FDA 510(k) Application Details - K210278

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K210278
Device Name	Staple, Implantable
Applicant	Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati, OH 45242 US Other 510(k) Applications for this Company
Contact	Alison Sathe Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2021
Decision Date	04/28/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review