510(k) K850906
K850906 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "TACTILE PLUS DENTAL ELEVATORS". The FDA issued a decision of Substantially Equivalent on April 12, 1985. The device falls under product code EMJ (Elevator, Surgical, Dental), a Class I device regulated under 21 CFR 872.4565. Ipco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1985
- Date Received
- March 5, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elevator, Surgical, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type