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510(k) K834171

Device
OP-CON SURG. INSTRUMENT #3
Applicant
IMM ENTERPRISES LTD.
510(k) number
K834171
Product code
KOA  
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-04
Date received
1983-11-21
Regulation
876.4730
Classification name
Surgical Instruments, G-u, Manual (and Accessories)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
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 KOA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182664FiXcisionAgency For Medical Innovations GmbH2018-12-07
K950267URETHRAL SUTURE GUIDEApplied Medical Resources1995-01-31
K932465LI VASECTOMYFemcare , Ltd.1994-03-02
K921546VASOVASOSTOMY SETCook Urological, Inc.1993-07-02
K931181VESITEC SUTURE PASSERVesitec Medical, Inc.1993-05-12
K921304DDV LIGATORNorth American Medical, Inc.1992-10-05
K922971NO-SCALPEL VASCETOMY INSTRUMENTSPilling Co.1992-09-23
K921228BENDEREV PROTECT-A-PASS NEEDLEEimark Labs, Inc.1992-09-14
K922192VAS DILATORCook Urological, Inc.1992-08-07
K896058GRASPING FORCEPSAnnex Medical, Inc.1989-12-28
K891352MARLOW ANAL SPECULUMSimpson/Basye, Inc.1989-06-23
K890218MICROSURGICAL CYSTOTOMEKinetic Medical Products1989-01-27
K864963STOMACH EVACULATOR - EWALD STYLEMedovations, Inc.1987-10-14
K863273MARTIN MEDICAL PRO-SCOPE ANOSCOPEMartin Medical1986-11-04
K852014EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINAEffner and Spreine Co.1985-08-07

Legacy Summary#

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FDA Review#

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