Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)— 510(k) K230610
Substantially EquivalentDongguan Shin YI Healthcare Products Factory
FDA 510(k) clearance K230610 for Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series), Substantially Equivalent on 2023-08-23. Applicant: Dongguan Shin YI Healthcare Products Factory. Device class: 2.
Clearance details
- Applicant
- Dongguan Shin YI Healthcare Products Factory
- 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
- Dong Guan, CN
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More clearances from Dongguan Shin YI Healthcare Products Factory
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