510(k) K801975
K801975 is an FDA 510(k) premarket notification submitted by Silverman'S for the device "LITTLE GIANT I & II HANDPIECE CONTROL". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Silverman'S has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1980
- Date Received
- August 19, 1980
- 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