FDA 510(k) Application Details - DEN230032

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230032
Device Name	Symani Surgical System
Applicant	MMI North America, Inc. 344 Ponte Vedra Blvd. Ponte Vedra, FL 32082 US Other 510(k) Applications for this Company
Contact	Mauro Ercolani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2023
Decision Date	04/05/2024
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review