Halyard ONE-STEP* Sterilization Wrap— 510(k) K192147
Substantially EquivalentOwens & Minor (O&M) Halyard, Inc.
FDA 510(k) clearance K192147 for Halyard ONE-STEP* Sterilization Wrap, Substantially Equivalent on 2019-10-10. Applicant: Owens & Minor (O&M) Halyard, Inc.. Device class: 2.
Clearance details
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
- Product code
- Code FRG
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mechanicsville, VA, US
Recent devices under product code FRG
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- K232777 — FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) +1 more
- K232807 — Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869) +1 more
- K232812 — Fluidshield* 2 Fog-Free Surgical Mask (62113) +3 more
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.