The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830.
| Device ID | K010714 |
| 510k Number | K010714 |
| Device Name: | EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDI-GLOBE CORP. MEDI-GLOB-STRASSE 1-5 Achenmuhle, DE |
| Contact | Gerhardt Seiwerth |
| Correspondent | Gerhardt Seiwerth MEDI-GLOBE CORP. MEDI-GLOB-STRASSE 1-5 Achenmuhle, DE |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-09 |
| Decision Date | 2003-01-21 |
| Summary: | summary |