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510(k) K821754

Device
A O FIBER OPTIC ILLUMINATOR, 1185B
Applicant
WARNER-LAMBERT CO.
510(k) number
K821754
Product code
FCR  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-24
Date received
1982-06-15
Regulation
876.1500
Classification name
Light Source, Photographic, Fiberoptic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FCR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K844774EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISSMecron Medical Products, Inc.1985-04-22
K821753A O FIBER OPTIC ILLUMINATION, 1185AWarner-Lambert Co.1982-06-24

Legacy Summary#

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FDA Review#

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