FDA 510(k) Application Details - K211401

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K211401
Device Name	Powered Laser Surgical Instrument
Applicant	Gyrus ACMI, Inc. 800 West Park Drive Westborough, MA 01581 US Other 510(k) Applications for this Company
Contact	Julie Acker Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2021
Decision Date	06/03/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review