FDA 510(k) Application Details - K122756

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K122756
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	PENUMBRA, INC. 1351 HARBOR BAY PARKWAY ALAMEDA, CA 94502 US Other 510(k) Applications for this Company
Contact	SETH SCHULMAN 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	09/07/2012
Decision Date	10/02/2012
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