The following data is part of a premarket notification filed by Origen Biomedical, Inc. with the FDA for Origen Bladder Holder.
| Device ID | K003145 |
| 510k Number | K003145 |
| Device Name: | ORIGEN BLADDER HOLDER |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | ORIGEN BIOMEDICAL, INC. 2525 HARTFORD RD. Austin, TX 78703 -2428 |
| Contact | Richard Martin |
| Correspondent | Richard Martin ORIGEN BIOMEDICAL, INC. 2525 HARTFORD RD. Austin, TX 78703 -2428 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2001-04-20 |