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510(k) K840101

Device
EYE SURGERY INSTRUMENT
Applicant
TRULINE INSTRUMENTS, INC.
510(k) number
K840101
Product code
HOB  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-16
Date received
1984-01-10
Regulation
886.4350
Classification name
Clamp, Muscle, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
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 HOB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K840310CATEGORY 6 OPTHALMIC DEVICESImm Enterprises , Ltd.1984-03-16
K780851CHARLES ENDOCOAGULATOR ACCESSORY FOR ARCVarian Assoc., Inc.1978-06-30

Legacy Summary#

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FDA Review#

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