510(k) K021083
K021083 is an FDA 510(k) premarket notification submitted by Lumalite, Inc. for the device "VERACAM". The FDA issued a decision of Substantially Equivalent on Aug 30, 2002. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Lumalite, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 30, 2002
- Date Received
- Apr 3, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
- 510(k)