The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterradd Sterilization System.
| Device ID | K954142 |
| 510k Number | K954142 |
| Device Name: | STERRADD STERILIZATION SYSTEM |
| Classification | Sterilizer, Steam |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Kevin Corrigan |
| Correspondent | Kevin Corrigan ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-01 |
| Decision Date | 1997-06-06 |