CARETEX SURGEON'S HOODS— 510(k) K880431
Substantially EquivalentJames River Corp.
FDA 510(k) clearance K880431 for CARETEX SURGEON'S HOODS, Substantially Equivalent on 1988-02-24. Applicant: James River Corp.. Device class: 2.
Clearance details
- Applicant
- James River Corp.
- Product code
- Code FXY
- 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
- Neenah, WI, US
Recent devices under product code FXY
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- K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
- K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
- K904969 — HOOD, OPERATING, SURGICAL
- K904276 — DISPOSABLE BEARD COVER
More clearances from James River Corp.
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