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 |