The following data is part of a premarket notification filed by Invatec S.p.a. with the FDA for Scuba Biliary Stent System.
| Device ID | K092352 |
| 510k Number | K092352 |
| Device Name: | SCUBA BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | INVATEC S.P.A. 3101 EMRICK BLVD Bethlehem, PA 18020 |
| Contact | Steve Camp |
| Correspondent | Steve Camp INVATEC S.P.A. 3101 EMRICK BLVD Bethlehem, PA 18020 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2010-03-16 |
| Summary: | summary |