EOGas 4 Endo-SteriTest RRBI— 510(k) K202879
Substantially EquivalentAndersen Sterilizers, Inc.
FDA 510(k) clearance K202879 for EOGas 4 Endo-SteriTest RRBI, Substantially Equivalent on 2021-03-03. Applicant: Andersen Sterilizers, Inc.. Device class: 2.
Clearance details
- Applicant
- Andersen Sterilizers, Inc.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haw River, NC, US
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