| Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
| 510(k) Number |
K244033 |
| Device Name |
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) |
| Applicant |
| Shenzhen Desida Technology Co., Ltd. |
| 5th Floor, Bldg. A, Sanmin Industrial Zone, Shilongzai, |
| Shuitian Community, Shiyan St., Baoan District |
|
Shenzhen,
CN
518109
|
|
| Applicant Contact |
Shuangcheng Yuan |
| Correspondent |
| Feiying Drug & Medical Consulting Technical Service Group |
| Rm.2401 Zhenye International Business Center, |
| # 3101-90 Qianhai Rd. |
|
Shenzhen,
CN
518052
|
|
| Correspondent Contact |
Youshan Gong |
| Regulation Number | 878.4780 |
| Classification Product Code |
|
| Date Received | 12/30/2024 |
| Decision Date | 05/16/2025 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
Ear Nose & Throat
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|