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510(k) K951519

Device
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
Applicant
WELLS JOHNSON CO.
510(k) number
K951519
Product code
FWL  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-14
Date received
1995-04-03
Regulation
878.4160
Classification name
Camera, Cine, Endoscopic, 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
BRENDA HUNT
Address
8075 E Research Ct., Suite 101 P.O. Box 18230 Tucson AZ US 85731 85731

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FWL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883760STORZ MODEL 62 ENT CAMERA SYSTEMStorz Instrument Co.1988-09-28

Legacy Summary#

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FDA Review#

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