DOUCHE UNIT-1500 ML DISP. CONTAINER— 510(k) K800957

Name: FDA 510(k) clearance K800957
Creator: U.S. Food and Drug Administration
Published: 1980-07-14

Substantially Equivalent

The Healthcare Group Laboratories, Inc.

FDA 510(k) clearance K800957 for DOUCHE UNIT-1500 ML DISP. CONTAINER, Substantially Equivalent on 1980-07-14. Applicant: The Healthcare Group Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: The Healthcare Group Laboratories, Inc.
Product code: Code HED
Device class: Class 1
Regulation: 21 CFR 884.5900
Advisory panel: Obstetrics/Gynecology
Date received: 1980-04-23
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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