510(k) K950743
K950743 is an FDA 510(k) premarket notification submitted by Transidyne General Corp. for the device "ORAL PROCEDURE PACK". The FDA issued a decision of Substantially Equivalent (kit) on March 31, 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. Transidyne General Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- March 31, 1995
- Date Received
- February 17, 1995
- 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