FDA 510(k) Application Details - K122246

Device Classification Name	Wound Cleaner, Ultrasound   More FDA Info for this Device
510(K) Number	K122246
Device Name	Wound Cleaner, Ultrasound
Applicant	CELLERATION, INC. 6321 BURY DRIVE, STE 15 EDEN PRAIRIE, MN 55346 US Other 510(k) Applications for this Company
Contact	KATHY SIMPSON Other 510(k) Applications for this Contact
Regulation Number	878.4410   More FDA Info for this Regulation Number
Classification Product Code	NRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2012
Decision Date	08/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review