510(k) K843742
K843742 is an FDA 510(k) premarket notification submitted by Unitek Corp. for the device "UNITEK CONVERTIBLE CAP REMOVER TOOL". The FDA issued a decision of Substantially Equivalent on November 9, 1984. The device falls under product code JEX (Plier, Orthodontic), a Class I device regulated under 21 CFR 872.4565. Unitek Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1984
- Date Received
- September 25, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plier, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type