Device Classification Name |
Gown, Surgical
|
510(k) Number |
K210215 |
Device Name |
Surgical Gowns |
Applicant |
Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
No.1 Jianerkang Road, Zhixi Industry Concentration Area, |
Zhixi Town |
Changzhou,
CN
213251
|
|
Applicant Contact |
Tang Hongfang |
Correspondent |
Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
No.1 Jianerkang Road, Zhixi Industry Concentration Area, |
Zhixi Town |
Changzhou,
CN
213251
|
|
Correspondent Contact |
Tang Hongfang |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 01/27/2021 |
Decision Date | 07/07/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|