The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Well Lead Extraction Bag.
| Device ID | K160801 |
| 510k Number | K160801 |
| Device Name: | Well Lead Extraction Bag |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | WELL LEAD MEDICAL CO., LTD. C-4 # JINHU INDUSTRIAL ESTATE, HUALONG, PANYU Guangzhou, CN 511434 |
| Contact | Han Guang Yuan |
| Correspondent | Han Guang Yuan WELL LEAD MEDICAL CO., LTD. C-4 # JINHU INDUSTRIAL ESTATE, HUALONG, PANYU Guangzhou, CN 511434 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-23 |
| Decision Date | 2016-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16944932741192 | K160801 | 000 |
| 16936881133746 | K160801 | 000 |
| 06936881133756 | K160801 | 000 |
| 16936881133760 | K160801 | 000 |
| 16936881133777 | K160801 | 000 |
| 06936881166488 | K160801 | 000 |
| 16936881166492 | K160801 | 000 |
| 06944932741157 | K160801 | 000 |
| 16944932741178 | K160801 | 000 |
| 16944932741185 | K160801 | 000 |
| 06936881133725 | K160801 | 000 |