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510(k) K854988

Device
KY-M280U SURGICAL CAMERA
Applicant
US JVC CORP.
510(k) number
K854988
Product code
FWC  
Decision
Substantially Equivalent (SESE)
Decision date
1986-01-24
Date received
1985-12-12
Regulation
878.4160
Classification name
Camera, Television, Surgical, With Audio
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TED MARKS
Address
41 Slater Dr. Elmwood Park NJ US 07407 07407

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FWC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890119BR-S601MU (SURGICAL VIDEO RECORDER)Victor Co. of Japan, Ltd. C/O Jvc Corp.1989-01-24
K864381LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEMLuxtec Corp.1986-12-09

Legacy Summary#

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FDA Review#

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