The following data is part of a premarket notification filed by Innerdyne, Inc. with the FDA for Innerdyne Radially Expanding Dilation, Red Device.
| Device ID | K990854 |
| 510k Number | K990854 |
| Device Name: | INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Rick Gaykowski |
| Correspondent | Rick Gaykowski INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | FGE |
| Subsequent Product Code | FFA |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | KGC |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-15 |
| Decision Date | 1999-08-02 |
| Summary: | summary |