The following data is part of a premarket notification filed by Hydrocision, Inc. with the FDA for Hydrocision General Surgery Fluidjet System.
| Device ID | K021813 |
| 510k Number | K021813 |
| Device Name: | HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM |
| Classification | Lavage, Jet |
| 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 | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-03 |
| Decision Date | 2003-05-09 |
| Summary: | summary |