510(k) K252575— Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)

Substantially Equivalent

New York Embroidery Studio (NYES)

Clearance details

Applicant: New York Embroidery Studio (NYES)
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2025-08-14
Decision date: 2026-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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