The following data is part of a premarket notification filed by Hydrocision, Inc. with the FDA for Hydrocision Arthrojet System With Cautery, Turboburr And Curette, Models 51300, 51310.
| Device ID | K032529 |
| 510k Number | K032529 |
| Device Name: | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 |
| Classification | Arthroscope |
| Applicant | HYDROCISION, INC. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro 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 | 2003-08-15 |
| Decision Date | 2003-09-16 |
| Summary: | summary |