HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL) +1 more— 510(k) K260310
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K260310 for HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL) +1 more, Substantially Equivalent on 2026-10-28. Applicant: O&M Halyard, Inc.. Device class: 2.
Clearance details
- Device name as filed
- HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
- Applicant
- O&M Halyard, Inc.
- Product code
- Product code QSO
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.