510(k) K100401
K100401 is an FDA 510(k) premarket notification submitted by Hu-Friedy Mfg. Co., Inc. for the device "SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 30, 2010. 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
- March 30, 2010
- Date Received
- February 16, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type