The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad 200 Sterilizer.
| Device ID | K030429 |
| 510k Number | K030429 |
| Device Name: | STERRAD 200 STERILIZER |
| Classification | Sterilizer, Chemical |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Natalie Bennington |
| Correspondent | Natalie Bennington ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-10 |
| Decision Date | 2003-08-18 |
| Summary: | summary |