The following data is part of a premarket notification filed by Reed Medical (zhejiang) Co., Ltd. with the FDA for Reedgyn Disposable Hysteroscope (model Rh-2s-01 And Model Rh-2d-01).
| Device ID | K190797 |
| 510k Number | K190797 |
| Device Name: | Reedgyn Disposable Hysteroscope (Model RH-2S-01 And Model RH-2D-01) |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Reed Medical (Zhejiang) Co., Ltd. 8th Floor, 10th Building, No. 988 Of Xinxing Two Road EDZ Of Pinghu Pinghu, CN 314200 |
| Contact | Lu Zhong Zhong |
| Correspondent | Daniel Qiu Shanghai Qisheng Business Consulting Co., Ltd. Room 1301, Bld 46, Jing Gu Zhong Rd. No. 58, Min Hang District, Shanghai, CN Shanghai, CN 200240 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-28 |
| Decision Date | 2019-11-18 |
| Summary: | summary |