BARRIER NEURO SHEET— 510(k) K760937
Substantially EquivalentSurgikos, Inc.
FDA 510(k) clearance K760937 for BARRIER NEURO SHEET, Substantially Equivalent on 1976-12-21. Applicant: Surgikos, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgikos, Inc.
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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