FDA.reportPublic FDA data

510(k) K820115

Device
EMMETT IUD THREAD RETREIVER
Applicant
PROTO-MED, INC.
510(k) number
K820115
Product code
HHF  
Decision
Substantially Equivalent (SESE)
Decision date
1982-02-05
Date received
1982-01-18
Regulation
884.4530
Classification name
Remover, Intrauterine Device, Contraceptive, Hook-type
Medical specialty
Obstetrics/Gynecology
Review panel
Toxicology
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 HHF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K926541IUD HOOKSThomasville Medical Assoc.1994-02-24
K891030IUD HOOKS - SIMPLE, UNIVERSAL AND SKLARZinnanti Surgical Instruments, Inc.1989-03-17
K842295INTRAUTERINE DEVICE REMOVERPremier Dental Products Co.1984-10-12
K831568RELIANCE TEMPO OPHTH. INSTR STANDF. & F. Koenigkramer1983-06-30
K811761THE EMMETT IUD THREAD RETRIEVERProto-Med, Inc.1981-09-21

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