FDA.reportPublic FDA data

510(k) K880196

Device
LAMINARIA
Applicant
MEDGYN PRODUCTS, INC.
510(k) number
K880196
Product code
HDY  
Decision
Substantially Equivalent (SESE)
Decision date
1988-05-06
Date received
1988-01-26
Regulation
884.4260
Classification name
Dilator, Cervical, Hygroscopic-laminaria
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LAKSHMAN AGADI
Address
2808 A. Center Cir. Downers Grove IL US 60515 60515

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HDY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040625ATAD ARD CATHETERAtad Developments , Ltd.2005-01-18
K021012LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLC2002-06-25
K011512MMODIFICATION TO LAMINARIAA & A Medical, Inc.2001-07-09
K955072LAMINARIACti Corp., Ltd.1996-05-22
K892220LAMINARIA TENTBerkeley Medevices1989-06-14
K881295LAMINARIA CUREXHarold W. Berger Co.1988-08-10
K881312LAMINARIABusse Hospital Disposables, Inc.1988-05-23
K845006SUN MEDICAL LAMINARIA CERVICAL DILATORSun Medical, Inc.1985-05-01
K833068LAMINARIA JAPONICA CERVICAL DILATORMedi-Spec1984-02-04
K782067DILATOR, MIZUTANI LAMINARIA TENTBritish Marketing Ent., Ltd.1979-01-03

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases