510(k) K871834
K871834 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "DRILL, HAND, BONE, SMEDBERG". The FDA issued a decision of Substantially Equivalent on July 31, 1987. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1987
- Date Received
- May 12, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Driver, Wire, And Bone Drill, Manual
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type