Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)— 510(k) K223401
Substantially EquivalentXiamen Probtain Medical Techology Co., Ltd.
FDA 510(k) clearance K223401 for Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL), Substantially Equivalent on 2023-03-07. Applicant: Xiamen Probtain Medical Techology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Xiamen Probtain Medical Techology 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
- Xiamen, CN
Recent devices under product code FYA
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- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
More clearances from Xiamen Probtain Medical Techology Co., Ltd.
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