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510(k) K934092

Device
CAMERA, SURGICAL AND ACCESSORIES
Applicant
ENVISION MEDICAL CORP.
510(k) number
K934092
Product code
FWB  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-07
Date received
1993-08-23
Regulation
878.4160
Classification name
Camera, Television, Surgical, Without Audio
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DANIEL P MCGUIRE
Address
7220 Hollister Ave. Goleta CA US 93117 93117

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FWB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K902359SURGICAL VIDEO CAMERA, MODEL 9500Seitz Technical Products, Inc.1990-07-12
K884343SONY COLOR VIDEO CAMERAS AND ACCESSORIESSony Corp. of America1988-11-01
K871057MC-SERIES SURGICAL CAMERASM.P. Video, Inc.1987-04-03
K855020MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930Medline Industries, Inc.1986-01-24
K820829MEDICAMM.P. Video, Inc.1982-05-03

Legacy Summary#

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FDA Review#

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