The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad Nx Sterilizer.
| Device ID | K042116 |
| 510k Number | K042116 |
| Device Name: | STERRAD NX 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 | 2004-08-05 |
| Decision Date | 2005-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705037015191 | K042116 | 000 |
| 10705037015184 | K042116 | 000 |
| 20705037014832 | K042116 | 000 |
| 10705037014132 | K042116 | 000 |