The following data is part of a premarket notification filed by Hydrocision, Inc. with the FDA for Hydrocision Spinejet System.
| Device ID | K200729 |
| 510k Number | K200729 |
| Device Name: | HydroCision SpineJet System |
| Classification | Arthroscope |
| Applicant | HydroCision, Inc. 267 Boston Rd, Suite 28 North Billerica, MA 01862 |
| Contact | Mark J Lewis |
| Correspondent | Yashesh Rawal MAE Consulting Group, LLC 119 North Road Deerfield, NH 03037 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-20 |
| Decision Date | 2020-04-16 |