510(k) K233068

Disposable Surgical Gown by Nanning Tecbod Biological Technology Co., Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2024
Date Received
September 26, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type