Comfort Gown, Safewear Gown— 510(k) K213893
Substantially EquivalentXuchang Zhengde Environstar Medical Products Co., Ltd.
FDA 510(k) clearance K213893 for Comfort Gown, Safewear Gown, Substantially Equivalent on 2022-12-21. Applicant: Xuchang Zhengde Environstar Medical Products Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Xuchang Zhengde Environstar Medical Products 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
- Xuchang, CN
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More clearances from Xuchang Zhengde Environstar Medical Products Co., Ltd.
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