Device Classification Name |
Apparatus, Suction, Ward Use, Portable, Ac-Powered
More FDA Info for this Device |
510(K) Number |
K090759 |
Device Name |
Apparatus, Suction, Ward Use, Portable, Ac-Powered |
Applicant |
BIODRAIN MEDICAL, INC.
2060 CENTRE POINTE BLVD
SUITE 7
MENDOTA HEIGHTS, MN 55120-1269 US
Other 510(k) Applications for this Company
|
Contact |
CHAD RUWE
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 |
03/23/2009 |
Decision Date |
04/01/2009 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
SU - General & Plastic Surgery |
Review Advisory Committee |
SU - General & Plastic Surgery |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
Y |
Expedited Review |
|