STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR— 510(k) K141580
Substantially EquivalentTso3, Inc.
FDA 510(k) clearance K141580 for STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR, Substantially Equivalent on 2014-12-17. Applicant: Tso3, Inc.. Device class: 2.
Clearance details
- Applicant
- Tso3, 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
- Vancouver, WA, US
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