The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Flo-rester(r) Vessel Sizer.
| Device ID | K905159 |
| 510k Number | K905159 |
| Device Name: | FLO-RESTER(R) VESSEL SIZER |
| Classification | Dilator, Vessel, Surgical |
| Applicant | BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Contact | Sheryl A Krattley |
| Correspondent | Sheryl A Krattley BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-16 |
| Decision Date | 1991-02-07 |