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510(k) K041237

Device
ECHOSAMPLER
Applicant
GYNETICS MEDICAL PRODUCTS NV
510(k) number
K041237
Product code
HFF  
Decision
Substantially Equivalent (SESE)
Decision date
2004-09-08
Date received
2004-05-11
Regulation
884.1060
Classification name
Aspirator, Endometrial
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GRACE HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K903002PROBET (TM)Gynopharma, Inc.1991-04-05
K902693WALLACH FLEXIBLE ENDOMETRIAL SAMPLERWallach Surgical Devices, Inc.1991-01-31
K831212ENDOSCANNAxcan Scientific Corp.1984-06-15
K820641ACCURETTEAxcan Scientific Corp.1982-06-22

Legacy Summary#

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FDA Review#

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