The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad 100nx Test Pack.
| Device ID | K071537 |
| 510k Number | K071537 |
| Device Name: | STERRAD 100NX TEST PACK |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Reuben Lawson |
| Correspondent | Reuben Lawson ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-05 |
| Decision Date | 2007-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705037047550 | K071537 | 000 |
| 10705037016501 | K071537 | 000 |
| 10705037016495 | K071537 | 000 |