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510(k) K831829

Device
KARICKHOFF FLYING CORPUSCLE VIEWER
Applicant
SURGIDEV CORP.
510(k) number
K831829
Product code
HIX  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-19
Date received
1983-06-07
Regulation
886.1435
Classification name
Maxwell Spot, Ac-powered
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 HIX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K801554STERILE CAST PADDINGMedi-Spec1980-08-04

Legacy Summary#

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FDA Review#

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