510(k) K911111
K911111 is an FDA 510(k) premarket notification submitted by Vermont Diamond Instruments for the device "MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS". The FDA issued a decision of Substantially Equivalent on November 19, 1991. The device falls under product code EHJ (Disk, Abrasive), a Class I device regulated under 21 CFR 872.6010. Vermont Diamond Instruments has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1991
- Date Received
- March 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Disk, Abrasive
- Device Class
- Class I
- Regulation Number
- 872.6010
- Review Panel
- DE
- Submission Type