The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad 100nx Sterilizer With Allcleartm Technology.
| Device ID | K160903 |
| 510k Number | K160903 |
| Device Name: | STERRAD 100NX Sterilizer With ALLClearTM Technology |
| Classification | Sterilizer, Chemical |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DRIVE Irvine, CA 92617 |
| Contact | Jamie Byun |
| Correspondent | Jamie Byun ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DRIVE Irvine, CA 92617 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705037048700 | K160903 | 000 |
| 10705037048694 | K160903 | 000 |
| 10705037048687 | K160903 | 000 |
| 10705037048670 | K160903 | 000 |