EDTA GEL (TM)— 510(k) K940737
Substantially EquivalentKarolinska Institutet
FDA 510(k) clearance K940737 for EDTA GEL (TM), Substantially Equivalent on 1994-06-03. Applicant: Karolinska Institutet. Device class: 2.
Clearance details
- Applicant
- Karolinska Institutet
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Potomac, MD, US
Recent devices under product code EBF
view allData sourced from openFDA. This site is unofficial and independent of the FDA.