K960441 is an FDA 510(k) clearance for the STERITEC INTEGRAPH MODEL CI-101. 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. (Aurora, US). The FDA issued a Cleared decision on May 8, 1997, 462 days after receiving the submission on February 1, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K960441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1996 |
| Decision Date | May 08, 1997 |
| Days to Decision | 462 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOJ - Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |