The following data is part of a premarket notification filed by Andrew Technologies, Llc with the FDA for Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4mm Dia, 26 Cm Length, 3 Aperture Reusable Cannula, 4mm Dia,.
| Device ID | K121218 |
| 510k Number | K121218 |
| Device Name: | HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, |
| Classification | System, Suction, Lipoplasty |
| Applicant | ANDREW TECHNOLOGIES, LLC 3 Haddon Avenue Haddonfield, NJ 08033 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane ANDREW TECHNOLOGIES, LLC 3 Haddon Avenue Haddonfield, NJ 08033 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-23 |
| Decision Date | 2012-12-13 |
| Summary: | summary |