The following data is part of a premarket notification filed by Medical Device Resource Corp. with the FDA for Lipisystems Aquavage, Models Av2000 And Av1200.
| Device ID | K092284 |
| 510k Number | K092284 |
| Device Name: | LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 |
| Classification | System, Suction, Lipoplasty |
| Applicant | MEDICAL DEVICE RESOURCE CORP. 23392 CONNECTICUT ST. Hayward, CA 94545 |
| Contact | Melbourne Kimsey |
| Correspondent | Melbourne Kimsey MEDICAL DEVICE RESOURCE CORP. 23392 CONNECTICUT ST. Hayward, CA 94545 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-29 |
| Decision Date | 2009-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70859898006408 | K092284 | 000 |
| 60859898006241 | K092284 | 000 |
| 00385640061452 | K092284 | 000 |
| 00385640061476 | K092284 | 000 |
| 00385640072250 | K092284 | 000 |