K981625 is an FDA 510(k) clearance for the STERRAD 50 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 January 11, 1999, 249 days after receiving the submission on May 7, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K981625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1998 |
| Decision Date | January 11, 1999 |
| Days to Decision | 249 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 |