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510(k) K840384

Device
DIAGNOSTIC DILATATION & MENSTRUAL KIT
Applicant
INTL. MEDICAL TECHNOLOGIES, INC.
510(k) number
K840384
Product code
HHI  
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-30
Date received
1984-01-30
Regulation
884.5070
Classification name
System, Abortion, Vacuum
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 HHI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171440Berkeley VC-10 Vacuum Curettage SystemGyrus Acmi2017-09-29
K030935BERKELEY V-10 VACUUM CURETTAGE SYSTEMAcmi Corporation2003-06-23
K983181CYTOPREPCytoprep Inc. Est.1998-11-16
K931205MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTERBaxter Healthcare Corp1994-03-15
K904160CYTOSMEAR BRUSHBrooke Intl.1990-11-02
K900641CANNULA, SUCTION UTERINEWilliams Specialty Products, Inc.1990-03-30
K900642SWIVEL ADAPTERWilliams Specialty Products, Inc.1990-03-19
K880734SCENTED OR SCENTED DEODORIZED MENSTRUAL PADSPersonal Products Co.1988-04-25
K873552CANNULA AND GENERAL PURPOSE ASPIRATORCosmedtech, Inc.1987-11-25
K870574COSMEDTECH GENERAL ASPIRATORCosmedtech, Inc.1987-03-05
K870560COSMEDTECH CANNULACosmedtech, Inc.1987-03-04
K862476LS3000 CANNULA UTERINE SUCTIONEngineering, Inc.1986-07-18
K850312GYNASPYR VACUUM CURETTAGE UNITRoseburg SA1985-02-28
K841631MODEL 3014 SUCTION UNITForma Scientific, Inc.1984-07-03
K840381TAPERED CERVICAL DILATORIntl. Medical Technologies, Inc.1984-04-30

Legacy Summary#

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FDA Review#

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