The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Cidex Opa Concentrate.
| Device ID | K032959 |
| 510k Number | K032959 |
| Device Name: | CIDEX OPA CONCENTRATE |
| Classification | Sterilant, Medical Devices |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Neelu Medhekar |
| Correspondent | Neelu Medhekar ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-23 |
| Decision Date | 2005-04-04 |
| Summary: | summary |