AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown— 510(k) K210688
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K210688 for AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown, Substantially Equivalent on 2021-07-21. Applicant: O&M Halyard, Inc.. Device class: 2.
Clearance details
- Applicant
- O&M Halyard, Inc.
- Product code
- Code FYA
- 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.