510(k) K261949— NYES Tuff Cuff L3 Disposable Gowns

Substantially Equivalent

New York Embroidery Studio

Clearance details

Applicant: New York Embroidery Studio
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2026-06-11
Decision date: 2026-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Brooklyn, NY, US

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