The following data is part of a premarket notification filed by Yangzhou Fartley Medical Instrument Technology Co., Ltd. with the FDA for Disposable Endoscopy Adapter Set.
Device ID | K220210 |
510k Number | K220210 |
Device Name: | Disposable Endoscopy Adapter Set |
Classification | Endoscope Channel Accessory |
Applicant | Yangzhou Fartley Medical Instrument Technology Co., Ltd. Beizhou Road, Lidian Town, Guangling District Yangzhou, CN 225106 |
Contact | Tina Han |
Correspondent | Ethan Liu Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai, CN 201100 |
Product Code | ODC |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-26 |
Decision Date | 2022-06-17 |