Disposable Surgical Gown, Disposable Reinforced Surgical Gown— 510(k) K212869
Substantially EquivalentFugou County Shenxiang Manufacturing Co., Ltd.
FDA 510(k) clearance K212869 for Disposable Surgical Gown, Disposable Reinforced Surgical Gown, Substantially Equivalent on 2021-12-13. Applicant: Fugou County Shenxiang Manufacturing Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Fugou County Shenxiang Manufacturing 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
- Zhoukou, CN
Recent devices under product code FYA
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Data sourced from openFDA. This site is unofficial and independent of the FDA.