510(k) DEN980003
DEN980003 is an FDA 510(k) premarket notification submitted by Diamond General Development Corp. for the device "DIAMOND PROBE/PERIO 2000 SYSTEM". The FDA issued a decision of De Novo Granted on July 17, 1998. The device falls under product code MVH (Device, Detection, Sulfide), a Class II device regulated under 21 CFR 872.1870.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 17, 1998
- Date Received
- May 18, 1998
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Detection, Sulfide
- Device Class
- Class II
- Regulation Number
- 872.1870
- Review Panel
- DE
- Submission Type