DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED— 510(k) K963548

Name: FDA 510(k) clearance K963548
Creator: U.S. Food and Drug Administration
Published: 1997-01-22

Substantially Equivalent

Mrlb Intl., Inc.

FDA 510(k) clearance K963548 for DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED, Substantially Equivalent on 1997-01-22. Applicant: Mrlb Intl., Inc.. Device class: 1.

Clearance details

Applicant: Mrlb Intl., Inc.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1996-09-05
Decision date: 1997-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Grand Forks, MN, 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.