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510(k) K833068

Device
LAMINARIA JAPONICA CERVICAL DILATOR
Applicant
MEDI-SPEC
510(k) number
K833068
Product code
HDY  
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-04
Date received
1983-09-08
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K880196LAMINARIAMedgyn Products, Inc.1988-05-06
K845006SUN MEDICAL LAMINARIA CERVICAL DILATORSun Medical, Inc.1985-05-01
K782067DILATOR, MIZUTANI LAMINARIA TENTBritish Marketing Ent., Ltd.1979-01-03

Legacy Summary#

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FDA Review#

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