Device Classification Name |
Gown, Surgical
|
510(k) Number |
K192560 |
Device Name |
Surgical Gown |
Applicant |
Shandong Kangli Medical Equipment Technology Co., Ltd. |
Huiquan East Road, Shizhong District |
Zaozhuang,
CN
277117
|
|
Applicant Contact |
Zhuang Liu |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 09/17/2019 |
Decision Date | 05/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|