The following data is part of a premarket notification filed by Fossa Medical, Inc. with the FDA for Fossa Ureteral Open Stents.
| Device ID | K072293 |
| 510k Number | K072293 |
| Device Name: | FOSSA URETERAL OPEN STENTS |
| Classification | Stent, Ureteral |
| Applicant | FOSSA MEDICAL, INC. 50 REDFIELD STREET Boston, MA 02122 |
| Contact | Gloria Kolb |
| Correspondent | Gloria Kolb FOSSA MEDICAL, INC. 50 REDFIELD STREET Boston, MA 02122 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-08-16 |
| Decision Date | 2008-08-06 |
| Summary: | summary |