0.55% ORTH-PHTHALALDEHYDE SOLUTION
FDA 510(k) clearance K030004 · decided 2003-02-27
Clearance details
- K-number
- K030004
- Device name
- 0.55% ORTH-PHTHALALDEHYDE SOLUTION
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2003-01-02
- Decision date
- 2003-02-27
- Days to decision
- 56 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat s recall (Z-2774-2015) | Advanced Sterilization Products | 2015-09-16 |
| CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyd recall (Z-2276-2012) | Advanced Sterilization Products | 2012-08-27 |