GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT— 510(k) K954562

Name: FDA 510(k) clearance K954562
Creator: U.S. Food and Drug Administration
Published: 1995-12-22

Substantially Equivalent

Gynetech, Inc.

FDA 510(k) clearance K954562 for GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT, Substantially Equivalent on 1995-12-22. Applicant: Gynetech, Inc.. Device class: 2.

Clearance details

Applicant: Gynetech, Inc.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1995-10-02
Decision date: 1995-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springdale, AR, 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.