The following data is part of a premarket notification filed by Sunny Medical Device (shenzhen) Co.,ltd. with the FDA for Sunmed Disposable Angio-closure Pads.
| Device ID | K191827 |
| 510k Number | K191827 |
| Device Name: | Sunmed Disposable Angio-Closure Pads |
| Classification | Clamp, Vascular |
| Applicant | Sunny Medical Device (Shenzhen) Co.,Ltd. 56 Lehigh Aisle Irvine, CA 92612 |
| Contact | James Qi Zhang |
| Correspondent | James Qi Zhang Sunny Medical Device (Shenzhen) Co.,Ltd. 56 Lehigh Aisle Irvine, CA 92612 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-08 |
| Decision Date | 2020-03-16 |