Silgreen Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Silgreen Inc., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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)"; 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 2026-09-30.
- 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)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html