Surgical Isolation Cover Gown— 510(k) K220528
Substantially EquivalentWuhan Dymex Healthcare Co., Ltd.
FDA 510(k) clearance K220528 for Surgical Isolation Cover Gown, Substantially Equivalent on 2022-06-10. Applicant: Wuhan Dymex Healthcare Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Wuhan Dymex Healthcare Co., Ltd.
- Product code
- Code FYC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuhan, CN
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