Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)— 510(k) K232849
Substantially EquivalentOwens & Minor (O&M) Halyard, Inc.
FDA 510(k) clearance K232849 for Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311), Substantially Equivalent on 2024-05-16. Applicant: Owens & Minor (O&M) Halyard, Inc.. Device class: 2.
Clearance details
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
- Product code
- Code FYC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mechanicsville, VA, US
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