The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Cidex Opa Solution (0.55% Orthro-phthalaldehyde Solution).
| Device ID | K002401 |
| 510k Number | K002401 |
| Device Name: | CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) |
| Classification | Sterilant, Medical Devices |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Neelu Medheker |
| Correspondent | Neelu Medheker ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2000-08-29 |