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 | K160625 |
| 510k Number | K160625 |
| 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 | 2016-03-04 |
| Decision Date | 2016-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26932503548520 | K160625 | 000 |
| 26932503548513 | K160625 | 000 |