510(k) K942480
K942480 is an FDA 510(k) premarket notification submitted by Kerr Corporation (Danbury) for the device "M4 CONTRA-ANGLE HANDPIECE". The FDA issued a decision of Substantially Equivalent on January 27, 1995. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Kerr Corporation (Danbury) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1995
- Date Received
- May 25, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type