HARWILL MEDICAL U-KLIP UMBILICAL CLAMP— 510(k) K983204

Name: FDA 510(k) clearance K983204
Creator: U.S. Food and Drug Administration
Published: 1999-02-26

Substantially Equivalent

Harwill Medical (Pty) , Ltd.

FDA 510(k) clearance K983204 for HARWILL MEDICAL U-KLIP UMBILICAL CLAMP, Substantially Equivalent on 1999-02-26. Applicant: Harwill Medical (Pty) , Ltd.. Device class: 2.

Clearance details

Applicant: Harwill Medical (Pty) , Ltd.
Product code: Code HFW
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1998-09-14
Decision date: 1999-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HFW

view all

K041332 — JOEY CLAMP OPENING TOOL2004-06-25
K033846 — KAEN YIH UMBILICAL CORD CLAMP2004-03-11
K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE2002-06-03
K021055 — BUSSE UMBILICAL CORD CLAMP CUTTER2002-04-29
K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B2001-11-28

More clearances from Harwill Medical (Pty) , Ltd.

view all

K992618 — RESPALERT1999-10-29
K983202 — HARWILL MEDICAL CERVITULA CERVICAL SPATULA1999-03-15
K980550 — WHISTLE WATCH1998-08-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.