The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Biliary And Pancreatic Endoprostheses (stents).
| Device ID | K010549 |
| 510k Number | K010549 |
| Device Name: | BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Contact | Scott Karler |
| Correspondent | Scott Karler MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2002-01-18 |