The following data is part of a premarket notification filed by Shenzhen Xinlianfeng Technology Co.,ltd with the FDA for Electric Nasal Aspirator.
Device ID | K222547 |
510k Number | K222547 |
Device Name: | Electric Nasal Aspirator |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | Shenzhen XinLianFeng Technology CO.,LTD No.5, Tongxi Road, Pingdong Community, Pingdi Street, Longgang District Shenzhen, CN 518000 |
Contact | Ma Qiang |
Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co.Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, CN 518107 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-08-23 |
Decision Date | 2022-10-20 |