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510(k) K972823

Device
Mini-embryon Intra Uterine Insemination Catheter
Applicant
A & A MEDICAL, INC.
510(k) number
K972823
Product code
MFD
Decision
Substantially Equivalent (SESE)
Decision date
1997-10-10
Date received
1997-07-30
Regulation
884.5250
Classification name
Cannula, Intrauterine Insemination
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ADIB KHOURY
Address
4100 Nine Mcfarland Dr., #B Alpharetta GA US 30201 30201

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MFD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021438INSEMINATION CATHETER, MODEL 320301Labotect Labor-Technik Gottingen2002-07-16
K012935THECURVE, ITEM 507Select Medical Systems, Inc.2001-10-11
K984306`THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.1999-03-01
K982630MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.1999-01-14
K982628MEDWORKS INSEMINATION CATHETERMedworks Corp.1998-08-21
K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTERRocket Medical Plc1998-03-02
K972245TOM CAT F.L., TOM CAT S.L.A & A Medical, Inc.1997-08-06
K970750MICROSPAN INSEMINATION SYSTEMImagyn Medical, Inc.1997-05-05
K964848WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CMMarlow Surgical Technologies, Inc.1997-01-16
K963031GENXCATHETERGenx Intl., Inc.1996-10-21
K962273MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NSTMarlo Surgical Technology1996-07-31
K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATIONAckrad Laboratories1996-04-23
K954398INSEMI-CATH IICook Urological, Inc.1995-12-19
K954099SELECT IUISelect Medical Systems, Inc.1995-11-22
K953719HUMAN TUBAL FLUIDLife Technologies, Inc.1995-11-06