510(k) K981234
K981234 is an FDA 510(k) premarket notification submitted by Lone Star Technologies for the device "FLARE,FILE, FILL". The FDA issued a decision of Substantially Equivalent on June 5, 1998. The device falls under product code EJB (Handle, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565. Lone Star Technologies has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 1998
- Date Received
- April 4, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handle, Instrument, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type