SEJONG Surgical Gown Soft— 510(k) K220435
Substantially EquivalentSejong Healthcare Co., Ltd.
FDA 510(k) clearance K220435 for SEJONG Surgical Gown Soft, Substantially Equivalent on 2023-02-10. Applicant: Sejong Healthcare Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Sejong Healthcare Co., Ltd.
- Product code
- Code FYA
- 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
- Paju Si, KR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.