HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR— 510(k) K990479

Name: FDA 510(k) clearance K990479
Creator: U.S. Food and Drug Administration
Published: 1999-05-13

Substantially Equivalent

Hygenitek, Inc.

FDA 510(k) clearance K990479 for HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR, Substantially Equivalent on 1999-05-13. Applicant: Hygenitek, Inc.. Device class: 1.

Clearance details

Applicant: Hygenitek, Inc.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1999-02-16
Decision date: 1999-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Markham, Ontario, CA

Download summary PDF View on FDA.gov ↗

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