NYES Tuff Cuff L3 Disposable Gowns— 510(k) K261949
Substantially EquivalentNew York Embroidery Studio
FDA 510(k) clearance K261949 for NYES Tuff Cuff L3 Disposable Gowns, Substantially Equivalent on 2026-07-10. Applicant: New York Embroidery Studio. Device class: 2.
Clearance details
- Applicant
- New York Embroidery Studio
- 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
- Special
- Location
- Brooklyn, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.