The following data is part of a premarket notification filed by Xuzhou Kernel Medical Equipment Co., Ltd with the FDA for Colposcope System.
| Device ID | K160341 |
| 510k Number | K160341 |
| Device Name: | Colposcope System |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD KERNEL MANSION, ECONOMIC DEVELOPMENT DISTRICT Xuzhou, CN 221004 |
| Contact | Jing Wang |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O BOX 120-119 Shanghai, CN 200120 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06928798600285 | K160341 | 000 |
| 06928798600278 | K160341 | 000 |
| 06928798600261 | K160341 | 000 |
| 06928798600254 | K160341 | 000 |
| 06928798600247 | K160341 | 000 |
| 06928798600230 | K160341 | 000 |