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510(k) K823767

Device
ERG-JET ELECTRODE
Applicant
LIFE-TECH INTL., INC.
510(k) number
K823767
Product code
HLF  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-08
Date received
1982-12-14
Regulation
886.1430
Classification name
Device, Measuring, Lens Radius, 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 HLF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930437MARCO STANDARD RADIUSGAUGESMarco Ophthalmic, Inc.1993-08-09
K862517BAUSCH & LOMB CONTACT LENS VIEWERBausch & Lomb, Inc.1986-08-11

Legacy Summary#

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FDA Review#

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