BARRIER SURGICAL HOOD— 510(k) K760855
Substantially EquivalentSurgikos, Inc.
FDA 510(k) clearance K760855 for BARRIER SURGICAL HOOD, Substantially Equivalent on 1976-11-03. Applicant: Surgikos, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgikos, Inc.
- 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
- Mchenry, IL, US
Recent devices under product code FXY
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- K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
- K904969 — HOOD, OPERATING, SURGICAL
- K904276 — DISPOSABLE BEARD COVER
More clearances from Surgikos, Inc.
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