The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad Nx Challenge Pack.
| Device ID | K042450 |
| 510k Number | K042450 |
| Device Name: | STERRAD NX CHALLENGE PACK |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Joseph M Ascenzi |
| Correspondent | Joseph M Ascenzi 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 | 2004-09-09 |
| Decision Date | 2005-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705037016556 | K042450 | 000 |