Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
510(k) Number |
K220126 |
Device Name |
Geonic Nasal Aspirator, Geonic Nasal Cleaner |
Applicant |
Geon Corporation |
No. 12, Gung Ye Road |
Hsi Hu, Chang Hwa Hsien,
TW
514
|
|
Applicant Contact |
Henry Chen |
Correspondent |
AlfaBeta Clinical Research Co., Ltd. |
Rm. R103, 1F., No. 8, Sec. 2, Shengyi Rd., |
Chupei City, Hsinchu County,
TW
30261
|
|
Correspondent Contact |
Wan-Chi Chang |
Regulation Number | 878.4780
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/18/2022 |
Decision Date | 02/02/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|