The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad (r) Cyclesure (r) 24 Biological Indicator.
| Device ID | K111375 |
| 510k Number | K111375 |
| Device Name: | STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Nancy Chu |
| Correspondent | Nancy Chu ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2012-09-14 |
| Summary: | summary |