The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Cidex Opa Solution.
| Device ID | K991487 |
| 510k Number | K991487 |
| Device Name: | CIDEX OPA SOLUTION |
| Classification | Sterilant, Medical Devices |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | John E Frind |
| Correspondent | John E Frind 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 | 1999-04-28 |
| Decision Date | 1999-10-08 |
| Summary: | summary |