FDA 510(k) Application Details - K190789

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K190789
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	Dornoch Medical Systems 200 North West Parkway Riverside, MO 64150 US Other 510(k) Applications for this Company
Contact	Larry Smith Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	JCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2019
Decision Date	04/24/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review