510(k) K771890
K771890 is an FDA 510(k) premarket notification submitted by Chayes Virginia, Inc. for the device "PERCEPTION SERIES DELIVERY SYS.". The FDA issued a decision of Substantially Equivalent on October 20, 1977. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Chayes Virginia, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1977
- Date Received
- October 6, 1977
- 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