510(k) K844250
K844250 is an FDA 510(k) premarket notification submitted by Osada Electric Co., Ltd. for the device "OSADA ENAC". The FDA issued a decision of Substantially Equivalent on January 23, 1985. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Osada Electric Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1985
- Date Received
- November 2, 1984
- 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