The following data is part of a premarket notification filed by Biodrain Medical, Inc. with the FDA for Biodrain Streamway Fluid Management System.
| Device ID | K090759 |
| 510k Number | K090759 |
| Device Name: | BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | BIODRAIN MEDICAL, INC. 2060 CENTRE POINTE BLVD SUITE 7 Mendota Heights, MN 55120 -1269 |
| Contact | Chad Ruwe |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-03-23 |
| Decision Date | 2009-04-01 |
| Summary: | summary |