510(k) K880739
K880739 is an FDA 510(k) premarket notification submitted by Dyonics, Inc. for the device "DYONICS DRILL GUIDE/ISOMETER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 21, 1988. The device falls under product code LXI (Guide, Drill, Ligament), a Class I device regulated under 21 CFR 878.4820. Dyonics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1988
- Date Received
- February 24, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Guide, Drill, Ligament
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- OR
- Submission Type