The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Disposable Hot Biopsy Forceps.
| Device ID | K180018 |
| 510k Number | K180018 |
| Device Name: | Disposable Hot Biopsy Forceps |
| Classification | Forceps, Biopsy, Electric |
| 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 | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-02 |
| Decision Date | 2018-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503548547 | K180018 | 000 |
| 16932503548530 | K180018 | 000 |