The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Embrella Endoscopic Distal Attachment.
| Device ID | K190030 |
| 510k Number | K190030 |
| Device Name: | Embrella Endoscopic Distal Attachment |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. NO. 10 Gaoke Third Road Nanjing, CN 210032 |
| Contact | Becky Li |
| Correspondent | Becky Li Micro-Tech (Nanjing) Co., Ltd. NO. 10 Gaoke Third Road Nanjing, CN 210032 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-07 |
| Decision Date | 2019-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503560822 | K190030 | 000 |
| 16932503560815 | K190030 | 000 |