The following data is part of a premarket notification filed by Ciden Technologies Llc with the FDA for Opaciden Solution.
| Device ID | K070627 |
| 510k Number | K070627 |
| Device Name: | OPACIDEN SOLUTION |
| Classification | Sterilant, Medical Devices |
| Applicant | CIDEN TECHNOLOGIES LLC 540 COLLEGE ST. Bellaire, TX 77401 -5010 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones CIDEN TECHNOLOGIES LLC 540 COLLEGE ST. Bellaire, TX 77401 -5010 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-06 |
| Decision Date | 2007-08-02 |
| Summary: | summary |