The following data is part of a premarket notification filed by Shenzhen Yuanxing Nano-pharma Co., Ltd with the FDA for Agem Ag Mesh Dressing With Silver.
| Device ID | K152544 |
| 510k Number | K152544 |
| Device Name: | Agem Ag Mesh Dressing With Silver |
| Classification | Dressing, Wound, Drug |
| Applicant | SHENZHEN YUANXING NANO-PHARMA CO., LTD ROOM 1001, RESOURCES-TECH-BUILDING, NO 1, SONGPINGSHAN RD, HI-TECH INDUSTRIAL PARK, NANSHAN DISTRICT Shenzhen, CN 518057 |
| Contact | Liu Longqing |
| Correspondent | Long Yang SHENZHEN HLONGMED BIOTECH COMPANY R15-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROAD, NANSHAN DISTRICT Shenzhen, CN 518054 |
| 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 | 2015-09-04 |
| Decision Date | 2016-05-23 |
| Summary: | summary |