The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Norta.
| Device ID | K935630 |
| 510k Number | K935630 |
| Device Name: | NORTA |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-23 |
| Decision Date | 1994-10-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NORTA 73687558 1486851 Dead/Cancelled |
BEIERSDORF AKTIENGESELLSCHAFT 1987-10-02 |
![]() NORTA 73351664 1222489 Dead/Cancelled |
Beiersdorf Aktiengesellschaft 1982-02-24 |