FDA 510(k) Application Details - K191328

Device Classification Name	Apparatus, Exhaust, Surgical   More FDA Info for this Device
510(K) Number	K191328
Device Name	Apparatus, Exhaust, Surgical
Applicant	Megadyne Medical Products, Inc. 1506 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	05/16/2019
Decision Date	07/26/2019
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