Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile— 510(k) K220665
Substantially EquivalentExcellent Medical Technology Group Co., Ltd.
FDA 510(k) clearance K220665 for Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile, Substantially Equivalent on 2022-06-03. Applicant: Excellent Medical Technology Group Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Excellent Medical Technology Group 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
- Suzhou, CN
Recent devices under product code FYA
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- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
Data sourced from openFDA. This site is unofficial and independent of the FDA.