The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad 100nx Sterilizer.
| Device ID | K071385 |
| 510k Number | K071385 |
| Device Name: | STERRAD 100NX STERILIZER |
| Classification | Sterilizer, Chemical |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Reuben Lawson |
| Correspondent | Reuben Lawson ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-18 |
| Decision Date | 2007-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705037014900 | K071385 | 000 |
| 10705037047598 | K071385 | 000 |
| 10705037047581 | K071385 | 000 |
| 10705037014507 | K071385 | 000 |
| 10705037014491 | K071385 | 000 |