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 |