The following data is part of a premarket notification filed by Nanosonics Limited with the FDA for Trophon Chemical Indicator.
| Device ID | K103126 |
| 510k Number | K103126 |
| Device Name: | TROPHON CHEMICAL INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | NANOSONICS LIMITED 24/566 GARDENERS ROAD Alexandria, Nsw, AU 2015 |
| Contact | Ron Weinberger |
| Correspondent | Ron Weinberger NANOSONICS LIMITED 24/566 GARDENERS ROAD Alexandria, Nsw, AU 2015 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-22 |
| Decision Date | 2011-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09350855000177 | K103126 | 000 |
| 09350855000054 | K103126 | 000 |
| 09350855000047 | K103126 | 000 |
| 09350855000542 | K103126 | 000 |