This page includes the latest FDA filings for Ami Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3014253920 | ||||||||||
| FEI Number | 3014253920 | ||||||||||
| Name | Sean Lee | ||||||||||
| Owner & Operator | AMI, Inc. | ||||||||||
| Contact Address | RM.1412, SJ Techno Ville, 278, Beotkkot-ro, Geumcheon-gu Seoul KR-NOTA 08511 KR | ||||||||||
| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||||||
| Initial Importer | N | ||||||||||
| Registration Expiration | 2020-04-25 | ||||||||||
| Registration Address | 5508 West Plano Parkway #200 Plano, TX 75093 US | ||||||||||
| Establishment Type |
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Device Company | Device | Date |
|---|---|---|
| AMI Inc. | BIOXEL | 2021-06-23 |
| AMI Inc. | Q-MASTER | 2021-06-23 |
AMI Inc. | Fractional CO2 Surgical Laser System | 2018-07-05 |
Sean Lee [AMI, Inc.] | CURELUX | 2018-03-01 |
Sean Lee [AMI, Inc.] | Q-MASTER Q-Switched Nd:YAG Laser System | 2017-12-15 |
Sean Lee [AMI, Inc.] | BIOXEL Fractional CO2 Surgical Laser System | 2017-12-15 |
AMI Inc. | Q-Switched Nd:YAG Laser System | 2017-12-07 |