510(k) K850666
K850666 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "STROBEX ULTRON ELECTROSURGE-DENTAL UNIT". The FDA issued a decision of Substantially Equivalent on May 29, 1985. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. Ipco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 1985
- Date Received
- February 20, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical, And Accessories, Dental
- Device Class
- Class II
- Regulation Number
- 872.4920
- Review Panel
- DE
- Submission Type