K030004 is an FDA 510(k) clearance for the 0.55% ORTH-PHTHALALDEHYDE SOLUTION. This device is classified as a Sterilant, Medical Devices (Class II - Special Controls, product code MED).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on February 27, 2003, 56 days after receiving the submission on January 2, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K030004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2003 |
| Decision Date | February 27, 2003 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MED — Sterilant, Medical Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6885 |