The following data is part of a premarket notification filed by Johnson & Johnson Co. with the FDA for Cidex Activated Dialdehyde Solution.
| Device ID | K060618 |
| 510k Number | K060618 |
| Device Name: | CIDEX ACTIVATED DIALDEHYDE SOLUTION |
| Classification | Sterilant, Medical Devices |
| Applicant | JOHNSON & JOHNSON CO. 33 TECHNOLOGY DR Irvine, CA 92618 |
| Contact | Joseph M Ascenzi |
| Correspondent | Joseph M Ascenzi JOHNSON & JOHNSON CO. 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 | 2006-03-08 |
| Decision Date | 2006-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705037044587 | K060618 | 000 |