The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad(r) 100nx Sterilizer Duo Cycle.
| Device ID | K111377 |
| 510k Number | K111377 |
| Device Name: | STERRAD(R) 100NX STERILIZER DUO CYCLE |
| Classification | Sterilizer, Chemical |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Nancy Chu |
| Correspondent | Nancy Chu 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 | 2011-05-16 |
| Decision Date | 2012-09-13 |
| Summary: | summary |