510(k) K770667
K770667 is an FDA 510(k) premarket notification submitted by Sterndent Corp. for the device "CHROMASCAN TM". The FDA issued a decision of Substantially Equivalent on April 20, 1977. The device falls under product code KZN (Scanner, Color), a Class II device regulated under 21 CFR 872.3661. Sterndent Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 1977
- Date Received
- April 8, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Color
- Device Class
- Class II
- Regulation Number
- 872.3661
- Review Panel
- DE
- Submission Type