CIDEX OPA CONCENTRATE
FDA 510(k) clearance K032959 · decided 2005-04-04
Clearance details
- K-number
- K032959
- Device name
- CIDEX OPA CONCENTRATE
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2003-09-23
- Decision date
- 2005-04-04
- Days to decision
- 559 days
- Clearance type
- Traditional
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.