DILATOR, MIZUTANI LAMINARIA TENT— 510(k) K782067

Name: FDA 510(k) clearance K782067
Creator: U.S. Food and Drug Administration
Published: 1979-01-03

Substantially Equivalent

British Marketing Ent., Ltd.

FDA 510(k) clearance K782067 for DILATOR, MIZUTANI LAMINARIA TENT, Substantially Equivalent on 1979-01-03. Applicant: British Marketing Ent., Ltd.. Device class: 2.

Clearance details

Applicant: British Marketing Ent., Ltd.
Product code: Code HDY
Device class: Class 2
Regulation: 21 CFR 884.4260
Advisory panel: Obstetrics/Gynecology
Date received: 1978-12-13
Decision date: 1979-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HDY

view all

K040625 — ATAD ARD CATHETER2005-01-18
K021012 — LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM2002-06-25
K011512 — MMODIFICATION TO LAMINARIA2001-07-09
K955072 — LAMINARIA1996-05-22
K892220 — LAMINARIA TENT1989-06-14

More clearances from British Marketing Ent., Ltd.

view all

K790032 — DISPOSABLE VACUUM CURETTE1979-02-01

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