STERRAAD 100NX EXPRESS CYCLE TEST PACK
FDA 510(k) clearance K092755 · decided 2011-02-25
Clearance details
- K-number
- K092755
- Device name
- STERRAAD 100NX EXPRESS CYCLE TEST PACK
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2009-09-09
- Decision date
- 2011-02-25
- Days to decision
- 534 days
- Clearance type
- Traditional
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.