CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown— 510(k) K210414
Substantially EquivalentMedtecs (Taiwan) Corp.
FDA 510(k) clearance K210414 for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown, Substantially Equivalent on 2022-10-21. Applicant: Medtecs (Taiwan) Corp.. Device class: 2.
Clearance details
- Applicant
- Medtecs (Taiwan) Corp.
- Product code
- Code FYC
- 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
- Taipei City, TW
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More clearances from Medtecs (Taiwan) Corp.
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