510(k) K950365
K950365 is an FDA 510(k) premarket notification submitted by Union Broach, Div. Moyco Industries, Inc. for the device "MOYCO-EDTA". The FDA issued a decision of Substantially Equivalent on Apr 27, 1995. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Union Broach, Div. Moyco Industries, Inc. has 13 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 1995
- Date Received
- Jan 31, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleanser, Root Canal
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)