Dream Medi Sterile Surgical Gown (SurgicalGownUL)— 510(k) K242937
Substantially EquivalentDae Myung Chemical Co., Ltd. (Vietnam)
FDA 510(k) clearance K242937 for Dream Medi Sterile Surgical Gown (SurgicalGownUL), Substantially Equivalent on 2025-05-05. Applicant: Dae Myung Chemical Co., Ltd. (Vietnam). Device class: 2.
Clearance details
- Applicant
- Dae Myung Chemical Co., Ltd. (Vietnam)
- 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
- Long Thanh, VN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.