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 |