Aero Blue Performance Surgical Gowns— 510(k) K192362
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K192362 for Aero Blue Performance Surgical Gowns, Substantially Equivalent on 2019-12-13. 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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Recalls naming K192362
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192362.
Data sourced from openFDA. This site is unofficial and independent of the FDA.