510(k) K101413
- Device
- EUROMI EVA SP6
- Applicant
- EUROMI SA
- 510(k) number
- K101413
- Product code
- MUU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-16
- Date received
- 2010-05-20
- Regulation
- 878.5040
- Classification name
- System, Suction, Lipoplasty
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- CURTIS RAYMOND
- Address
- 80 Shelton Technology Center Shelton CT US 06484 06484
FDA Registration Numbers
- 3009103001
- 3005670221
- 3022978896
- 1045254
- 3038715747
- 3007279404
- 3003587189
- 3008837339
- 3011163668
- 2028523
- 1645337
- 1220246
- 3011423170
- 3006611221
- 2030624
- 2523676
- 3006142527
- 3007593903
- 3009039068
- 2435119
- 1222928
- 1118193
- 3004878380
- 2032098
- 3007697975
- 3030230686
- 1058584
- 2027804
- 3010400367
- 2030580
- 2032809
- 1313525
- 2022994
- 3007829657
- 3002807523
- 3011533696
- 1047843
- 3022320321
- 3008717566
- 2020601
- 3009420598
- 3018094310
- 3038613815
- 3004112621
- 1000655158
- 3014903258
- 3003755939
Source Documents
Other 510(k) Records For Product Code MUU
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit | Millennium Medical Technologies Inc (Dba Cellmyx) | 2022-03-16 |
| K203800 | SyntrFuge System | Syntr Health Technologies, Inc. | 2021-07-02 |
| K202443 | Smart Kit Basic, Smart Kit Pro | Bsl Co., Ltd. | 2021-03-11 |
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | Lifecell Corporation | 2020-05-28 |
| K193363 | Dermapose Refresh | Puregraft, LLC | 2020-04-14 |
| K182732 | JTL-250-01 | Jointechlabs, Inc. | 2019-11-18 |
| K191564 | Progenikine Concentrating System 25 mL System | Emcyte Corporation | 2019-11-07 |
| K190386 | KTA Adipose Treatment Kit | Stemics S.A.S | 2019-10-10 |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123) | Auragen Aesthetics, LLC | 2019-05-03 |
| K172717 | Automatic Tissue Processing Unit | Bsl Co. | 2018-05-25 |
| K172714 | LipiVage | Genesis Biosystems, Inc. | 2017-12-08 |
| K163647 | Revolve Envi 600 Advanced Adipose System | Lifecell Corporation | 2017-08-25 |
| K171242 | Alma LipoFlow System | Alma Lasers, Inc. | 2017-07-14 |
| K171135 | Lipogems System | Lipogems International Spa | 2017-05-18 |
| K170449 | Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection | Millennium Medical Technologies, Inc. | 2017-03-31 |
Legacy Summary
summary
FDA Review
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