The following data is part of a premarket notification filed by Hydrocision, Inc. with the FDA for Arthrojet Xt.
| Device ID | K041233 |
| 510k Number | K041233 |
| Device Name: | ARTHROJET XT |
| Classification | Arthroscope |
| Applicant | HYDROCISION, INC. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Imampietro |
| Correspondent | Debbie Imampietro HYDROCISION, INC. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-07-28 |
| Summary: | summary |