FDA 510(k) Application Details - K200320

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K200320
Device Name	Staple, Implantable
Applicant	M/s. Meril Endo Surgery Private Limited Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg Chala, Vapi 396191 IN Other 510(k) Applications for this Company
Contact	Umesh Sharma 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	02/07/2020
Decision Date	02/05/2021
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