510(k) K790640
K790640 is an FDA 510(k) premarket notification submitted by E.C. Moore Co. for the device "HOWMEDICA BRASS CENTER DISC". The FDA issued a decision of Substantially Equivalent on May 1, 1979. The device falls under product code EHJ (Disk, Abrasive), a Class I device regulated under 21 CFR 872.6010.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 1979
- Date Received
- March 30, 1979
- 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