The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad Nx Sterilizer, Sterrad 100nx Sterilizer.
| Device ID | K151725 |
| 510k Number | K151725 |
| Device Name: | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer |
| Classification | Sterilizer, Chemical |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Contact | Sun Choi |
| Correspondent | Sun Choi ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DRIVE 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 | 2015-06-26 |
| Decision Date | 2016-01-13 |
| Summary: | summary |