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510(k) K252575

Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) by New York Embroidery Studio (NYES) — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2026
Date Received
August 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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