510(k) K012070
K012070 is an FDA 510(k) premarket notification submitted by Trylon Corp. for the device "ORALLITE COMPREHENSIVE EXAM TRAY". The FDA issued a decision of Substantially Equivalent on November 27, 2001. The device falls under product code MPU (Source, Chemiluminescent Light), a Class II device regulated under 21 CFR 884.4530. Trylon Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2001
- Date Received
- July 2, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Chemiluminescent Light
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type