K232849

Substantially Equivalent

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

Applicant: Owens & Minor (O&M) Halyard, Inc.
Product code: FYC
Advisory panel: General, Plastic Surgery
Date received: 2023-09-14
Decision date: 2024-05-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mechanicsville, VA, US

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