KALGINATE IMPRESSION MATERIAL— 510(k) K970594

Name: FDA 510(k) clearance K970594
Creator: U.S. Food and Drug Administration
Published: 1997-03-31

Substantially Equivalent

Teledyne Water Pik

FDA 510(k) clearance K970594 for KALGINATE IMPRESSION MATERIAL, Substantially Equivalent on 1997-03-31. Applicant: Teledyne Water Pik. Device class: 2.

Clearance details

Applicant: Teledyne Water Pik
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1997-02-18
Decision date: 1997-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Collins, CO, US

Download summary PDF View on FDA.gov ↗

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