PERSONAL SITZ BATH KIT— 510(k) K800958

Name: FDA 510(k) clearance K800958
Creator: U.S. Food and Drug Administration
Published: 1980-05-02

Substantially Equivalent

The Healthcare Group Laboratories, Inc.

FDA 510(k) clearance K800958 for PERSONAL SITZ BATH KIT, Substantially Equivalent on 1980-05-02. Applicant: The Healthcare Group Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: The Healthcare Group Laboratories, Inc.
Product code: Code KTC
Device class: Class 1
Regulation: 21 CFR 890.5125
Advisory panel: Physical Medicine
Date received: 1980-04-23
Decision date: 1980-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, US

Download summary PDF View on FDA.gov ↗

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