Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K240039 |
Device Name |
Enteral Feeding Sets |
Applicant |
Hangzhou Primecare Medical Co., Ltd. |
Room 408-409, Zancheng Center West, Shangcheng District |
Hang zhou,
CN
310008
|
|
Applicant Contact |
Li Xuedong |
Correspondent |
Hangzhou Primecare Medical Co., Ltd. |
Room 408-409, Zancheng Center West, Shangcheng District |
Hang zhou,
CN
310008
|
|
Correspondent Contact |
Li Xuedong |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/05/2024 |
Decision Date | 04/17/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|