The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad 50 Sterilizer.
| Device ID | K981625 |
| 510k Number | K981625 |
| Device Name: | STERRAD 50 STERILIZER |
| Classification | Sterilizer, Chemical |
| 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 | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-07 |
| Decision Date | 1999-01-11 |
| Summary: | summary |