FDA 510(k) Application Details - K192566

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K192566
Device Name	Staple, Implantable
Applicant	Reach Surgical, Inc. 120 Xinxing Road West Zone, TEDA Tianjin 300462 CN Other 510(k) Applications for this Company
Contact	Mark Goldin 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	09/18/2019
Decision Date	10/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review