The following data is part of a premarket notification filed by Hydrocision, Inc. with the FDA for Hydrocision Arthrojet System With Cautery And Burr.
| Device ID | K002764 |
| 510k Number | K002764 |
| Device Name: | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-05 |
| Decision Date | 2000-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853235007326 | K002764 | 000 |
| 00853235007142 | K002764 | 000 |
| 00853235007135 | K002764 | 000 |
| 00853235007128 | K002764 | 000 |
| 00853235007111 | K002764 | 000 |
| 00853235007104 | K002764 | 000 |
| 00853235007098 | K002764 | 000 |
| 00853235007081 | K002764 | 000 |
| 00853235007074 | K002764 | 000 |
| 00853235007067 | K002764 | 000 |
| 00853235007050 | K002764 | 000 |
| 00853235007043 | K002764 | 000 |
| 00853235007036 | K002764 | 000 |
| 00853235007029 | K002764 | 000 |
| 00853235007012 | K002764 | 000 |
| 00853235007005 | K002764 | 000 |
| 00853235007159 | K002764 | 000 |
| 00853235007166 | K002764 | 000 |
| 00853235007319 | K002764 | 000 |
| 00853235007302 | K002764 | 000 |
| 00853235007296 | K002764 | 000 |
| 00853235007289 | K002764 | 000 |
| 00853235007272 | K002764 | 000 |
| 00853235007265 | K002764 | 000 |
| 00853235007258 | K002764 | 000 |
| 00853235007241 | K002764 | 000 |
| 00853235007234 | K002764 | 000 |
| 00853235007227 | K002764 | 000 |
| 00853235007210 | K002764 | 000 |
| 00853235007203 | K002764 | 000 |
| 00853235007197 | K002764 | 000 |
| 00853235007180 | K002764 | 000 |
| 00853235007173 | K002764 | 000 |
| 00853235007333 | K002764 | 000 |