510(k) K910090
K910090 is an FDA 510(k) premarket notification submitted by Instrumentations Unltd. for the device "DIMAC WIRES". The FDA issued a decision of Substantially Equivalent on July 25, 1991. The device falls under product code DYX (Lock, Wire, And Ligature, Intraoral), a Class II device regulated under 21 CFR 872.4600. Instrumentations Unltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1991
- Date Received
- January 9, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lock, Wire, And Ligature, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.4600
- Review Panel
- DE
- Submission Type