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510(k) K842295

Device
INTRAUTERINE DEVICE REMOVER
Applicant
PREMIER DENTAL PRODUCTS CO.
510(k) number
K842295
Product code
HHF  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-12
Date received
1984-06-11
Regulation
884.4530
Classification name
Remover, Intrauterine Device, Contraceptive, Hook-type
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM J FREZEL
Address
P.O. Box 111 Norristown PA US 19404 19404

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
K831568RELIANCE TEMPO OPHTH. INSTR STANDF. & F. Koenigkramer1983-06-30
K820115EMMETT IUD THREAD RETREIVERProto-Med, Inc.1982-02-05
K811761THE EMMETT IUD THREAD RETRIEVERProto-Med, Inc.1981-09-21

Legacy Summary#

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FDA Review#

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