Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)— 510(k) K203539
Substantially EquivalentUnicoglobal, Inc.
FDA 510(k) clearance K203539 for Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE), Substantially Equivalent on 2021-12-10. Applicant: Unicoglobal, Inc.. Device class: 2.
Clearance details
- Applicant
- Unicoglobal, Inc.
- 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
- Seongnam, KR
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More clearances from Unicoglobal, Inc.
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