The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Flo-rester Disposable Vessel Occluder.
| Device ID | K942812 |
| 510k Number | K942812 |
| Device Name: | FLO-RESTER DISPOSABLE VESSEL OCCLUDER |
| Classification | Clamp, Vascular |
| Applicant | BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Contact | Bruce A Macfarlane, Ph.d. |
| Correspondent | Bruce A Macfarlane, Ph.d. BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-14 |
| Decision Date | 1994-08-01 |