The following data is part of a premarket notification filed by Ellman International, Inc. with the FDA for Disc-fx System.
| Device ID | K052241 |
| 510k Number | K052241 |
| Device Name: | DISC-FX SYSTEM |
| Classification | Arthroscope |
| Applicant | ELLMAN INTERNATIONAL, INC. 3333 ROYAL AVENUE Oceanside, NY 11572 |
| Contact | Joan Carter |
| Correspondent | Joan Carter ELLMAN INTERNATIONAL, INC. 3333 ROYAL AVENUE Oceanside, NY 11572 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-17 |
| Decision Date | 2006-02-24 |
| Summary: | summary |