The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad 50 & Sterrad 100s Sterilizers.
| Device ID | K023290 |
| 510k Number | K023290 |
| Device Name: | STERRAD 50 & STERRAD 100S STERILIZERS |
| Classification | Sterilizer, Ethylene-oxide Gas |
| 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 | FLF |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-02 |
| Decision Date | 2003-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705037014580 | K023290 | 000 |
| 10705037014460 | K023290 | 000 |