HARWILL MEDICAL CERVITULA CERVICAL SPATULA— 510(k) K983202

Name: FDA 510(k) clearance K983202
Creator: U.S. Food and Drug Administration
Published: 1999-03-15

Substantially Equivalent

Harwill Medical (Pty) , Ltd.

FDA 510(k) clearance K983202 for HARWILL MEDICAL CERVITULA CERVICAL SPATULA, Substantially Equivalent on 1999-03-15. Applicant: Harwill Medical (Pty) , Ltd.. Device class: 2.

Clearance details

Applicant: Harwill Medical (Pty) , Ltd.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1998-09-14
Decision date: 1999-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, 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.