FDA.reportPublic FDA data

510(k) K910518

Device
GLOVE-N-GEL AMNIOTOMY KIT
Applicant
EPCOM MEDICAL SYSTEMS, INC.
510(k) number
K910518
Product code
HGE  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1991-05-09
Date received
1991-02-06
Regulation
884.4530
Classification name
Amniotome
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL ULBRICH
Address
302 Lindbergh Ave. Livermore CA US 94550 94550

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HGE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951148OBSTI-HOOKOnli1995-06-09
K926425AMNIPERF(TM)Raymart Development Co.1994-03-07
K871087S.C.M.T. PERFORATORSalt Creek Medical Technologies1987-03-23
K850758AMNIGLOVE & AMNICOTGo Medical Industries Pty. , Ltd.1985-04-15
K834177H.R. JAKOBI SURG. INSTRUMENTS #4 30/31Imm Enterprises , Ltd.1983-12-27

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases