KENTEX DISPOSABLE VAGINAL SPECULUM— 510(k) K030693

Name: FDA 510(k) clearance K030693
Creator: U.S. Food and Drug Administration
Published: 2003-08-27

Substantially Equivalent

Kentron Health Care, Inc.

FDA 510(k) clearance K030693 for KENTEX DISPOSABLE VAGINAL SPECULUM, Substantially Equivalent on 2003-08-27. Applicant: Kentron Health Care, Inc.. Device class: 2.

Clearance details

Applicant: Kentron Health Care, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2003-03-05
Decision date: 2003-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, TN, US

Download summary PDF View on FDA.gov ↗

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