510(k) K070975
K070975 is an FDA 510(k) premarket notification submitted by Hu-Friedy Mfg. Co., Inc. for the device "SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES". The FDA issued a decision of Substantially Equivalent on June 21, 2007. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Hu-Friedy Mfg. Co., Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2007
- Date Received
- April 6, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type