Guangzhou Xiubo Medical Equipment Co. Ltd · 89-08 · CHINA
For Guangzhou Xiubo Medical Equipment Co. Ltd · 89-08 · CHINA, 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 CHINA; 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 2026-09-16.
- 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 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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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