510(k) K930151
K930151 is an FDA 510(k) premarket notification submitted by Innovative Technology , Ltd. for the device "OMNI-MATRIX". The FDA issued a decision of Substantially Equivalent on September 23, 1993. The device falls under product code JEP (Retainer, Matrix), a Class I device regulated under 21 CFR 872.4565. Innovative Technology , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1993
- Date Received
- January 12, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retainer, Matrix
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type