The following data is part of a premarket notification filed by Andrew Technologies, Llc with the FDA for Hydrasolve Lipoplasty System.
Device ID | K130152 |
510k Number | K130152 |
Device Name: | HYDRASOLVE LIPOPLASTY SYSTEM |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-22 |
Decision Date | 2013-04-18 |
Summary: | summary |