Dilator, Mizutani Laminaria Tent

FDA 510(k) K782067 · British Marketing Ent., Ltd.

Substantially Equivalent

510(k) numberK782067

Submission

Device name
Dilator, Mizutani Laminaria Tent
Applicant
British Marketing Ent., Ltd.
Walker, MI, US
Received
December 13, 1978
Decision date
January 3, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HDY – Dilator, Cervical, Hygroscopic-Laminaria
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4260
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HDY

510(k)DeviceApplicantDecision
K040625Atad Ard CatheterHDY · Traditional Atad Developments , Ltd.01/18/2005SE
K021012Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMHDY · Traditional Quality Medical Solusions, LLC06/25/2002SE
K011512Mmodification to LaminariaHDY · Traditional A & A Medical, Inc.07/09/2001SE
K955072LaminariaHDY · Traditional Cti Corp., Ltd.05/22/1996SE
K892220Laminaria TentHDY · Traditional Berkeley Medevices06/14/1989SE
K881295Laminaria CurexHDY · Traditional Harold W. Berger Co.08/10/1988SE
K881312LaminariaHDY · Traditional Busse Hospital Disposables, Inc.05/23/1988SE
K880196LaminariaHDY · Traditional Medgyn Products, Inc.05/06/1988SE
K845006Sun Medical Laminaria Cervical DilatorHDY · Traditional Sun Medical, Inc.05/01/1985SE
K833068Laminaria Japonica Cervical DilatorHDY · Traditional Medi-Spec02/04/1984SE

More from Medi-Spec

510(k)DeviceDecision
K790032Disposable Vacuum CuretteHCY · Traditional 02/01/1979SE

Questions and answers

When was Dilator, Mizutani Laminaria Tent cleared by the FDA?

Dilator, Mizutani Laminaria Tent (K782067) received a 510(k) decision of Substantially Equivalent on January 3, 1979, 21 days after the submission was received.

What is the product code of K782067?

The FDA product code is HDY – Dilator, Cervical, Hygroscopic-Laminaria, a Class II (moderate risk) device regulated under 21 CFR 884.4260.