BARNER SHOE COVERS & COVERBOOTS— 510(k) K760779
Substantially EquivalentSurgikos, Inc.
FDA 510(k) clearance K760779 for BARNER SHOE COVERS & COVERBOOTS, Substantially Equivalent on 1976-11-02. Applicant: Surgikos, Inc.. Device class: 1.
Clearance details
- Applicant
- Surgikos, Inc.
- Product code
- Code FXP
- Device class
- Class 1
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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