510(k) K070627
K070627 is an FDA 510(k) premarket notification submitted by Ciden Technologies, LLC for the device "OPACIDEN SOLUTION". The FDA issued a decision of Substantially Equivalent on August 2, 2007. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Ciden Technologies, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2007
- Date Received
- March 6, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilant, Medical Devices
- Device Class
- Class II
- Regulation Number
- 880.6885
- Review Panel
- HO
- Submission Type