Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K223401
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K223401
Device Name
Gown, Surgical
Applicant
Xiamen Probtain Medical Techology Co., Ltd
4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District
Xiamen 361100 CN
Other 510(k) Applications for this Company
Contact
Jianli Kang
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FYA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/09/2022
Decision Date
03/07/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact