The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Gip/medi-globe Ercp Catheters.
| Device ID | K953827 |
| 510k Number | K953827 |
| Device Name: | GIP/MEDI-GLOBE ERCP CATHETERS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Contact | Gina M Gallegos |
| Correspondent | Gina M Gallegos MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-15 |
| Decision Date | 1995-09-01 |