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510(k) K941035

Device
VENOSCOPE
Applicant
TRINITY PARTNERS, LLC.
510(k) number
K941035
Product code
HJN  
Decision
Substantially Equivalent (SESE)
Decision date
1994-05-16
Date received
1994-03-07
Regulation
886.1945
Classification name
Transilluminator, Battery-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
FRANK C CREAGHAN
Address
P.O. Box 52703 Lafayette LA US 70505 70505

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HJN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K912747LULMITEX NEONATAL TRANSILLUMINATORLumitex, Inc.1991-12-24
K901309SYLVAN PEDIASCAN 200 TRANSILLUMINATORSylvan Corp.1990-05-24

Legacy Summary#

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FDA Review#

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