The following data is part of a premarket notification filed by Fossa Medical, Inc. with the FDA for Fossa Ureteral Open Lumen Stent.
| Device ID | K033368 |
| 510k Number | K033368 |
| Device Name: | FOSSA URETERAL OPEN LUMEN STENT |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | FOSSA MEDICAL, INC. 580 HARRISON AVE., 4TH FL. Boston, MA 02118 |
| Contact | Gloria Kolb |
| Correspondent | Gloria Kolb FOSSA MEDICAL, INC. 580 HARRISON AVE., 4TH FL. Boston, MA 02118 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-21 |
| Decision Date | 2003-11-26 |
| Summary: | summary |