510(k) K090135
K090135 is an FDA 510(k) premarket notification submitted by Remicalm, LLC for the device "TRIMIRA IDENTAFI 3000". The FDA issued a decision of Substantially Equivalent on February 17, 2009. The device falls under product code NXV (Diagnostic Light, Soft Tissue Detector), a Class II device regulated under 21 CFR 872.6350. Remicalm, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2009
- Date Received
- January 21, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diagnostic Light, Soft Tissue Detector
- Device Class
- Class II
- Regulation Number
- 872.6350
- Review Panel
- DE
- Submission Type
To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities