The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Blue Beacon Submucosal Injectable Solution.
| Device ID | K200071 |
| 510k Number | K200071 |
| Device Name: | Blue Beacon Submucosal Injectable Solution |
| Classification | Submucosal Injection Agent |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. NO. 10 Gaoke Third Road Nanjing, CN 210032 |
| Contact | Sally He |
| Correspondent | Sally He Micro-Tech (Nanjing) Co., Ltd. NO. 10 Gaoke Third Road Nanjing, CN 210032 |
| Product Code | PLL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503562529 | K200071 | 000 |
| 16932503562512 | K200071 | 000 |