510(k) K924993
K924993 is an FDA 510(k) premarket notification submitted by Glenroe Technologies for the device "GLENROE BAND SEATING CONTOURING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on November 25, 1992. The device falls under product code ECS (Pusher, Band, Orthodontic), a Class I device regulated under 21 CFR 872.4565. Glenroe Technologies has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1992
- Date Received
- October 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pusher, Band, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type