STERRAD 100NX TEST PACK
FDA 510(k) clearance K071537 · decided 2007-12-18
Clearance details
- K-number
- K071537
- Device name
- STERRAD 100NX TEST PACK
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2007-06-05
- Decision date
- 2007-12-18
- Days to decision
- 196 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.