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510(k) K843388

Device
WELLINGTON HOSPITAL PATTERN SELF-RETAIN
Applicant
DOWNS SURGICAL LTD.
510(k) number
K843388
Product code
HDF  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-01
Date received
1984-08-29
Regulation
884.4520
Classification name
Speculum, Vaginal, Metal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
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 HDF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K926429VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTThomasville Medical Assoc.1994-02-28
K902019MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPSGynescope Corp.1990-06-07
K891041MIYA SPECULUMZinnanti Surgical Instruments, Inc.1989-03-22
K891044LASER SPECULAZinnanti Surgical Instruments, Inc.1989-03-17
K890375VAGINAL SPECULUMKinetic Medical Products1989-02-13
K862478HAYES VAGINAL SHIELDFranklin Medical USA, Inc.1986-11-24
K853640WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINALDowns Surgical , Ltd.1985-10-29
K85179961-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRAArtiberia1985-05-22
K821291PEDERSON VAGINAL SPECULAConphar, Inc.1982-05-24
K821297GRAVES SPECULAConphar, Inc.1982-05-24

Legacy Summary#

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FDA Review#

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