510(k) K970649
K970649 is an FDA 510(k) premarket notification submitted by Micro-Mega for the device "HERO 642". The FDA issued a decision of Substantially Equivalent on May 16, 1997. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. Micro-Mega has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1997
- Date Received
- February 20, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- File, Pulp Canal, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type