K000502 is an FDA 510(k) clearance for the STEAM/EO RECORD CARD, MODEL CI 121. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Steritec Products Mfg Co, Inc. (Castle Rock, US). The FDA issued a Cleared decision on March 14, 2000, 28 days after receiving the submission on February 15, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K000502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2000 |
| Decision Date | March 14, 2000 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | JOJ - Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |