50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown— 510(k) K192290
Substantially EquivalentXuchang Zhengde Environstar Medical Products Co., Ltd.
FDA 510(k) clearance K192290 for 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown, Substantially Equivalent on 2020-04-30. 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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