CG Bio Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For CG Bio Co., Ltd. · 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 MAYFILL Deep Cross-linked Hyaluronic Acid | MAYFILL Volume Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | MAYFILL Deep Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | MAYFILL Volume Cross-linked Hyaluronic Acid; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 01/13/2025; address is 29 Jeyakdanji-Ro , Hyangnam-Eup , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- CG Bio Co., Ltd. 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
- 29 Jeyakdanji-Ro , Hyangnam-Eup , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 01/13/2025 verified
- Product code
- 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular each item verified
- Product
- MAYFILL Deep Cross-linked Hyaluronic Acid | MAYFILL Volume Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | MAYFILL Deep Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | MAYFILL Volume Cross-linked Hyaluronic Acid each item verified
What the source says
CG Bio Co., Ltd. Date Published : 01/13/2025 29 Jeyakdanji-Ro , Hyangnam-Eup , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 01/13/2025 Desc: MAYFILL Deep Cross-linked Hyaluronic Acid 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 01/13/2025 Desc: MAYFILL Volume Cross-linked Hyaluronic Acid 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 01/13/2025 Desc: Cross-linked Hyaluronic Acid 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 01/13/2025 Desc: MAYFILL Deep Cross-linked Hyaluronic Acid 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 01/13/2025 Desc: Cross-linked Hyaluronic Acid 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 01/13/2025 Desc: MAYFILL Volume Cross-linked Hyaluronic Acid
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html