The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Wellead Endoscopic Seal.
| Device ID | K211814 |
| 510k Number | K211814 |
| Device Name: | Wellead Endoscopic Seal |
| Classification | Endoscope Channel Accessory |
| Applicant | Well Lead Medical CO., LTD. No. 47 Guomao Avenue South, Hualong, Panyu Guangzhou, CN 511434 |
| Contact | Caroline Gong |
| Correspondent | Caroline Gong Well Lead Medical CO., LTD. No. 47 Guomao Avenue South, Hualong, Panyu Guangzhou, CN 511434 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-11 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16944932785127 | K211814 | 000 |
| 16944932785110 | K211814 | 000 |