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510(k) K911163

Device
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS
Applicant
IMAGYN MEDICAL, INC.
510(k) number
K911163
Product code
FWF  
Decision
Substantially Equivalent (SESE)
Decision date
1991-06-03
Date received
1991-03-15
Regulation
878.4160
Classification name
Camera, Television, Endoscopic, Without Audio
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
VAN OSDEL
Address
920 Calle Negocio San Clemente CA US 92672 92672

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FWF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K053412FLEXISCOPE, MODELS 50MH AND 50 MHCSchoelly Imaging, Inc.2006-02-23
K990154KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMKarl Storz Imaging, Inc.1999-06-01
K982754EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)A.Stein - Regulatory Affairs Consulting1999-01-08
K982965ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIESRichard Wolf Medical Instruments Corp.1998-11-23
K982397VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEMAngiolaz, Inc.1998-09-10
K982409VES 1501-MAngiolaz, Inc.1998-08-21
K981819ANGIOLAZ VES-1CAMAngiolaz, Inc.1998-08-04
K944707ISOLATED CAMERA HEADEnvision Medical Corp.1994-10-07
K930297FUJINON VIDEO LAPAROSCOPE, MODIFIEDFujinon, Inc.1994-03-29
K934682SURGICAL VIDEO CAMERA AND ACCESSORIESMedical Dynamics, Inc.1994-02-15
K932628ENDOSCOPIC VIDEO CAMERAStephen Chakoff, Inc.1993-10-15
K926166COAST VIDEO ENDOSCOPIC IMAGING SYSTEMOptik1993-06-01
K930053VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10Medical Devices, Inc.1993-05-17
K925108INTEGRATED VISUALIZATION SYSTEMNeuro Navigational Corp.1993-01-29
K9231603DSCOPEAmerican Surgical Technologies Corp.1992-12-10

Legacy Summary#

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FDA Review#

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