FDA 510(k) Application Details - K191460

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K191460
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	Applied Tissue Technologies LLC 99 Derby St., Suite 700 Hingham, MA 02043 US Other 510(k) Applications for this Company
Contact	Michael Broomhead Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	OMP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2019
Decision Date	07/02/2019
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