The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Norta (tm) Urobag.
| Device ID | K870504 |
| 510k Number | K870504 |
| Device Name: | NORTA (TM) UROBAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Contact | Vincent Milano |
| Correspondent | Vincent Milano BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-04 |
| Decision Date | 1987-04-01 |