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510(k) K834174

Device
OP-CON SURGICAL INSTRUMENTS #4
Applicant
IMM ENTERPRISES LTD.
510(k) number
K834174
Product code
HCZ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-12-27
Date received
1983-11-21
Regulation
884.4530
Classification name
Forceps, Surgical, Gynecological
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 HCZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172661Fetzer Medical Gynecological ForcepsFetzer Medical GmbH & Co. KG2018-05-08
K134047JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPSIntegra LifeSciences Corporation2014-04-11
K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALInstrumed International, Inc.2009-12-03
K944055FORCEPS, SURGICAL GYNECOLOGICALOwens Precision Systems, Inc.1994-09-20
K941528PEARL PACKING FORCEPSCook Urological, Inc.1994-05-12
K926533Z-CLAMP FORCEPSThomasville Medical Assoc.1994-02-25
K926531HYSTERECTOMY FORCEPSThomasville Medical Assoc.1994-02-25
K926484CORSON MYOMA GRASPING FORCEPSThomasville Medical Assoc.1994-02-25
K930799VARIOUS FORCEPSThomasville Medical Assoc.1994-02-24
K930039FORCEPS: MCGRAVEY, MCINDOE, GILLISThomasville Medical Assoc.1994-02-24
K926528OVUM FORCEPSThomasville Medical Assoc.1994-02-24
K911474LAPAROSCOPIC FORCEPSUnited States Endoscopy Group, Inc.1991-07-03
K903707DEFLECTING WIRE GRASPERCook, Inc.1990-09-26
K901897ZEPPELIN FORCEPSKirwan Surgical Products, Inc.1990-06-29
K892820FORCEPS, SURGICAL, GYNECOLOGICALThe South India Surgical Co. Pvt. , Ltd.1989-06-22

Legacy Summary#

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FDA Review#

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