The following data is part of a premarket notification filed by Navarre Biomedical Ltd. with the FDA for Navarre Percutaneous Biliary Drainage.
| Device ID | K955110 |
| 510k Number | K955110 |
| Device Name: | NAVARRE PERCUTANEOUS BILIARY DRAINAGE |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH Plymouth, MN 55447 |
| Contact | Kelly Behrendt |
| Correspondent | Kelly Behrendt NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH Plymouth, MN 55447 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-08 |
| Decision Date | 1996-11-07 |
| Summary: | summary |