STERRAD 50 & STERRAD 100S STERILIZERS
FDA 510(k) clearance K023290 · decided 2003-04-03
Clearance details
- K-number
- K023290
- Device name
- STERRAD 50 & STERRAD 100S STERILIZERS
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2002-10-02
- Decision date
- 2003-04-03
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- FLF
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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