The following data is part of a premarket notification filed by Hydrocision, Inc. with the FDA for Hydrocision Arthrojet System With Cautery.
| Device ID | K993009 |
| 510k Number | K993009 |
| Device Name: | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY |
| Classification | Arthroscope |
| Applicant | HYDROCISION, INC. 220 BALLARDVALE ST. Wilmington, MA 01887 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro HYDROCISION, INC. 220 BALLARDVALE ST. Wilmington, MA 01887 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 1999-10-25 |
| Summary: | summary |