The following data is part of a premarket notification filed by Foshan United Medical Technologies, Ltd. with the FDA for Algs6 Ag Alginate Wound Dressing.
| Device ID | K172570 |
| 510k Number | K172570 |
| Device Name: | ALGS6 Ag Alginate Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Foshan United Medical Technologies, Ltd. 89 Taoyuan East Road, Shishan, Nanhai Foshan, CN 528225 |
| Contact | Una Chen |
| Correspondent | Albert Rego Albert Rego, Ph.D. Inc. 27001 La Paz Road, Suite #314 Mission Viejo, CA 92691 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-08-28 |
| Decision Date | 2018-05-11 |
| Summary: | summary |