The following data is part of a premarket notification filed by Bel-med, Inc. with the FDA for Norsen Debrider.
| Device ID | K821801 |
| 510k Number | K821801 |
| Device Name: | NORSEN DEBRIDER |
| Classification | Brush, Dermabrasion, Manual |
| Applicant | BEL-MED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GED |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-15 |
| Decision Date | 1982-07-28 |