Guangzhou Xiubo Medical Equipment Co. Ltd · 89-08 · CHINA
For Guangzhou Xiubo Medical Equipment Co. Ltd, import alert is 89-08; country is CHINA; 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 OTESALY Cross-linked Hyaluronic Acid w/lidocaine | OTESALY Cross-linked Hyaluronic Acid w/lidocaine; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 04/06/2017; address is No. 22 Tian Yuan Road, Baiyun District , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- Guangzhou Xiubo Medical Equipment 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
- CHINA verified
- Address
- No. 22 Tian Yuan Road, Baiyun District , Guangzhou, Guangdong CHINA verified
- Date published
- 04/06/2017 verified
- Product code
- 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular each item verified
- Product
- OTESALY Cross-linked Hyaluronic Acid w/lidocaine | OTESALY Cross-linked Hyaluronic Acid w/lidocaine each item verified
- FDA notes
- Class III device without a premarket approval (PMA) | Class III device without a premarket approval (PMA) each item verified
What the source says
Guangzhou Xiubo Medical Equipment Co. Ltd Date Published : 04/06/2017 No. 22 Tian Yuan Road, Baiyun District , Guangzhou, Guangdong CHINA
— 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
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/06/2017 Desc: OTESALY Cross-linked Hyaluronic Acid w/lidocaine Notes: Class III device without a premarket approval (PMA) 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 04/06/2017 Desc: OTESALY Cross-linked Hyaluronic Acid w/lidocaine Notes: Class III device without a premarket approval (PMA)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html