510(k) K812239
K812239 is an FDA 510(k) premarket notification submitted by Unitek Corp. for the device "UNITEK PALATAL BAR". The FDA issued a decision of Substantially Equivalent on September 21, 1981. The device falls under product code DYT (Maintainer, Space Preformed, Orthodontic), a Class I device regulated under 21 CFR 872.5525. Unitek Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1981
- Date Received
- August 11, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Maintainer, Space Preformed, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.5525
- Review Panel
- DE
- Submission Type