The following data is part of a premarket notification filed by Maersk Medical A/s with the FDA for 4l Drainage Bag, 4l Bag For Peritoneal Dialysis, 4l Urinary Drainage Bag.
| Device ID | K973364 |
| 510k Number | K973364 |
| Device Name: | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | MAERSK MEDICAL A/S HARLEV MARK 2 Harlev, DK 4652 |
| Contact | Joergen M Nielsen |
| Correspondent | Joergen M Nielsen MAERSK MEDICAL A/S HARLEV MARK 2 Harlev, DK 4652 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-08 |
| Decision Date | 1998-03-17 |
| Summary: | summary |