The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Cytology Brush.
| Device ID | K172663 |
| 510k Number | K172663 |
| Device Name: | Cytology Brush |
| Classification | Endoscopic Cytology Brush |
| 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 | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2018-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503549070 | K172663 | 000 |
| 16932503549063 | K172663 | 000 |
| 16932503549056 | K172663 | 000 |
| 16932503549049 | K172663 | 000 |
| 16932503549032 | K172663 | 000 |
| 16932503549025 | K172663 | 000 |
| 16932503549018 | K172663 | 000 |