STERRAD® NX Sterilizer With ALLClear™ Technology
Sterilizer, Chemical
ADVANCED STERILIZATION PRODUCTS
The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad® Nx Sterilizer With Allclear™ Technology.
Pre-market Notification Details
| Device ID | K160818 |
| 510k Number | K160818 |
| Device Name: | STERRAD® NX Sterilizer With ALLClear™ 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 | 2016-03-24 |
| Decision Date | 2016-09-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705037048656 | K160818 | 000 |
Trademark Results [STERRAD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERRAD 73805992 1584504 Live/Registered |
JOHNSON & JOHNSON 1989-06-12 |
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