The following data is part of a premarket notification filed by Navarre Biomedical Ltd. with the FDA for Navarre 600 Ml Drainage Bag.
| Device ID | K943663 |
| 510k Number | K943663 |
| Device Name: | NAVARRE 600 ML DRAINAGE BAG |
| Classification | Bag, Bile Collecting |
| Applicant | NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH Plymouth, MN 55447 |
| Contact | Gregg S Sutton |
| Correspondent | Gregg S Sutton NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH Plymouth, MN 55447 |
| Product Code | EXF |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-28 |
| Decision Date | 1994-09-08 |