FDA 510(k) Application Details - K210600

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K210600
Device Name	Marker, Radiographic, Implantable
Applicant	MOLLI Surgical, Inc. 22 St. Clair Ave. East, Suite #1500 Toronto M4t 2s3 CA Other 510(k) Applications for this Company
Contact	Fazila Seker Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	NEU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2021
Decision Date	04/16/2021
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