FDA 510(k) Application Details - K200250

Device Classification Name	Apparatus, Exhaust, Surgical   More FDA Info for this Device
510(K) Number	K200250
Device Name	Apparatus, Exhaust, Surgical
Applicant	Megadyne Medical Products, Inc. 11506 S State St Draper, UT 84020 US Other 510(k) Applications for this Company
Contact	Sharon Sussex Other 510(k) Applications for this Contact
Regulation Number	878.5070   More FDA Info for this Regulation Number
Classification Product Code	FYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2020
Decision Date	06/26/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review