510(k) K013993
K013993 is an FDA 510(k) premarket notification submitted by Stephen M Koral, Dmd for the device "NEOCALEX". The FDA issued a decision of Substantially Equivalent on February 22, 2002. The device falls under product code EIK (Carver, Wax, Dental), a Class I device regulated under 21 CFR 872.4565. Stephen M Koral, Dmd has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2002
- Date Received
- December 4, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carver, Wax, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type