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510(k) K864381

Device
LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM
Applicant
LUXTEC CORP.
510(k) number
K864381
Product code
FWC  
Decision
Substantially Equivalent (SESE)
Decision date
1986-12-09
Date received
1986-11-05
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
THOMAS WILK
Address
P.O. Box 225, Rte. 20/49 Techno Park Rd. Sturbridge MA US 01566 01566

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
K854988KY-M280U SURGICAL CAMERAUs Jvc Corp.1986-01-24

Legacy Summary#

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FDA Review#

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