510(k) K831749
K831749 is an FDA 510(k) premarket notification submitted by Union Branch for the device "ENDODONTIC BROACH(76EKN) BARBED BROACH". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code EKW (Broach, Endodontic), a Class I device regulated under 21 CFR 872.4565. Union Branch has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1983
- Date Received
- May 23, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Broach, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type