The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Guidant Megalink Biliary Stent, Model Fg1002949-58.
Device ID | K991032 |
510k Number | K991032 |
Device Name: | GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
Contact | Kobby Dankwah |
Correspondent | Kobby Dankwah GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-29 |
Decision Date | 1999-04-30 |
Summary: | summary |