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510(k) K821082

Device
TRIAL LENS SET
Applicant
MEDICAL EQUIPMENT DESIGNS, INC.
510(k) number
K821082
Product code
HLH  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-14
Date received
1982-04-19
Regulation
886.1700
Classification name
Pupillometer, Manual
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 HLH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K821083P.D. METERMedical Equipment Designs, Inc.1982-06-14

Legacy Summary#

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FDA Review#

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