The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Modification To Viabahn Endoprosthesis.
| Device ID | K023811 |
| 510k Number | K023811 |
| Device Name: | MODIFICATION TO VIABAHN ENDOPROSTHESIS |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P.O. BOX 900 Flagstaff, AZ 86002 -0900 |
| Contact | Timothy J Rynn |
| Correspondent | Timothy J Rynn W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P.O. BOX 900 Flagstaff, AZ 86002 -0900 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-15 |
| Decision Date | 2002-12-10 |
| Summary: | summary |