The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad 100nx Sterilizer Express Cycle.
| Device ID | K092622 |
| 510k Number | K092622 |
| Device Name: | STERRAD 100NX STERILIZER EXPRESS 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 | 2009-08-26 |
| Decision Date | 2011-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705037068166 | K092622 | 000 |