The Standard Company · 89-08 · KOREA (THE REPUBLIC OF)
For The Standard Company · 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 Mesotherapy Roller | Mesotherapy Roller | Mesotherapy Roller; product code is 53 - - - -- Cosmetics | 79 G - - ED Brush, Dermabrasion, Manual | 80 F - - MI Needle, Hypodermic, Single Lumen; date published is 11/29/2010; address is 1007 Byucksan 2cha, 481-10 , Gasan-Dong, Geumcheaon-Gu , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- The Standard Company 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
- 1007 Byucksan 2cha, 481-10 , Gasan-Dong, Geumcheaon-Gu , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 11/29/2010 verified
- Product code
- 53 - - - -- Cosmetics | 79 G - - ED Brush, Dermabrasion, Manual | 80 F - - MI Needle, Hypodermic, Single Lumen each item verified
- Product
- Mesotherapy Roller | Mesotherapy Roller | Mesotherapy Roller each item verified
- FDA notes
- Class II | Class II | Class II each item verified
What the source says
The Standard Company Date Published : 11/29/2010 1007 Byucksan 2cha, 481-10 , Gasan-Dong, Geumcheaon-Gu , Seoul, KOREA (THE REPUBLIC OF) 53 - - - -- Cosmetics Date Published: 11/29/2010 Desc: Mesotherapy Roller Notes: Class II 79 G - - ED Brush, Dermabrasion, Manual Date Published: 11/29/2010 Desc: Mesotherapy Roller Notes: Class II 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 11/29/2010 Desc: Mesotherapy Roller 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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