The following data is part of a premarket notification filed by Ciden Technologies Llc with the FDA for Opa 30 Solution.
Device ID | K140703 |
510k Number | K140703 |
Device Name: | OPA 30 SOLUTION |
Classification | Sterilant, Medical Devices |
Applicant | CIDEN TECHNOLOGIES LLC 1717 W. COLLINS AVE. Orange, CA 92867 |
Contact | Courtney Clark |
Correspondent | Courtney Clark CIDEN TECHNOLOGIES LLC 1717 W. COLLINS AVE. Orange, CA 92867 |
Product Code | MED |
CFR Regulation Number | 880.6885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-20 |
Decision Date | 2014-08-19 |
Summary: | summary |