K030429 is an FDA 510(k) clearance for the STERRAD 200 STERILIZER. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on August 18, 2003, 189 days after receiving the submission on February 10, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K030429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2003 |
| Decision Date | August 18, 2003 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |