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510(k) K881515

Device
TEAR VOLUME TESTS
Applicant
VISIONEX, INC.
510(k) number
K881515
Product code
KYD  
Decision
Substantially Equivalent (SESE)
Decision date
1988-05-23
Date received
1988-04-11
Regulation
886.1800
Classification name
Strip, Schirmer
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JESSICA AYRES
Address
1206 Sargent Dr. Sunnyvale CA US 94087 94087

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KYD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K911734TEARTEC RAPID LACRIMAL ASSESMENT SYSTEMNorthland Cataract & Eye Care Clinic1991-11-07
K832181SNO STRIPS STERILE TEARFLOW TEST STRIPSmith & Nephew, Inc.1983-08-12

Legacy Summary#

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FDA Review#

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