EDTA CAVIT— 510(k) K970246

Substantially Equivalent

Karolinski

FDA 510(k) clearance K970246 for EDTA CAVIT, Substantially Equivalent on 1997-04-16. Applicant: Karolinski. Device class: 2.

Clearance details

Applicant: Karolinski
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1997-01-21
Decision date: 1997-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.