510(k) K003567
K003567 is an FDA 510(k) premarket notification submitted by Corinthian Medical , Ltd. for the device "SERENOCEM, MODEL BC 010". The FDA issued a decision of Substantially Equivalent on February 12, 2001. The device falls under product code NEA (Cement, Ear, Nose And Throat), a Class II device regulated under 21 CFR 872.3275.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2001
- Date Received
- November 20, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Ear, Nose And Throat
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- EN
- Submission Type