Across Co., Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Across 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 REVOLAX | REVOLAX | REVOLAX; product code is 60 Q - - 40 Lidocaine HCl (Anesthetic) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 08/22/2022; address is 3F, 23, Geodudanji 1-gil , Dongnae-myeon , Chuncheon-si, Gangwon-do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Across 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
- 3F, 23, Geodudanji 1-gil , Dongnae-myeon , Chuncheon-si, Gangwon-do KOREA (THE REPUBLIC OF) verified
- Date published
- 08/22/2022 verified
- Product code
- 60 Q - - 40 Lidocaine HCl (Anesthetic) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular each item verified
- Product
- REVOLAX | REVOLAX | REVOLAX each item verified
What the source says
Across Co., Ltd Date Published : 08/22/2022 3F, 23, Geodudanji 1-gil , Dongnae-myeon , Chuncheon-si, Gangwon-do KOREA (THE REPUBLIC OF) 60 Q - - 40 Lidocaine HCl (Anesthetic) Date Published: 08/22/2022 Desc: REVOLAX 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 08/22/2022 Desc: REVOLAX 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 08/22/2022 Desc: REVOLAX
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.