Silgreen Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Silgreen Inc. · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is KOREA (THE REPUBLIC OF); product is Iontophoresis device for non-CF diagnosis (Skin care appliance) | Iontophoresis device for non-CF diagnosis (Skin care appliance); product code is 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - SA Massager, Therapeutic, Electric; date published is 01/24/2012; address is 396-2, Daebang-Dong, Dongjak-Ku , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Silgreen Inc. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 396-2, Daebang-Dong, Dongjak-Ku , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 01/24/2012 verified
- Product code
- 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Iontophoresis device for non-CF diagnosis (Skin care appliance) | Iontophoresis device for non-CF diagnosis (Skin care appliance) each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Silgreen Inc. Date Published : 01/24/2012 396-2, Daebang-Dong, Dongjak-Ku , Seoul, KOREA (THE REPUBLIC OF) 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 01/24/2012 Desc: Iontophoresis device for non-CF diagnosis (Skin care appliance) Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/24/2012 Desc: Iontophoresis device for non-CF diagnosis (Skin care appliance) Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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