Device Classification Name |
gown, surgical
|
510(k) Number |
K211060 |
Device Name |
Disposable Surgical Gown Rk-3011C |
Applicant |
Xiantao Rhycom Non-woven Products Co., Ltd |
Chuangye Road, Longhuashan Sub-district, |
Xiantao,
CN
|
|
Applicant Contact |
Liu Yang |
Correspondent |
PureVision Ai, Inc. |
111 Town Square Place Suite 1203 |
Jersey City,
NJ
07310 -2784
|
|
Correspondent Contact |
Bryan Wong |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 04/09/2021 |
Decision Date | 10/28/2022 |
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
|
|
|