Anprolene SteriTest RRBI— 510(k) K213296
Substantially EquivalentAndersen Sterilizers, Inc.
FDA 510(k) clearance K213296 for Anprolene SteriTest RRBI, Substantially Equivalent on 2022-04-12. 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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