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510(k) K844364

Device
SKIASCOPIC RACKS
Applicant
LUNEAU LABORATORIES
510(k) number
K844364
Product code
HMH  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-02
Date received
1984-11-13
Regulation
886.1750
Classification name
Rack, Skiascopic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HMH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843195VISITEC FLIERINGA-LEGRAND FIXATION RINGVisitec Co.1984-10-05

Legacy Summary#

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FDA Review#

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