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510(k) K901309

Device
SYLVAN PEDIASCAN 200 TRANSILLUMINATOR
Applicant
SYLVAN CORP.
510(k) number
K901309
Product code
HJN  
Decision
Substantially Equivalent (SESE)
Decision date
1990-05-24
Date received
1990-03-20
Regulation
886.1945
Classification name
Transilluminator, Battery-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES G FEDORKA
Address
P.O. Box 362, 612 Cedar St. Irwin PA US 15642 15642

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
K941035VENOSCOPETrinity Partners, LLC1994-05-16
K912747LULMITEX NEONATAL TRANSILLUMINATORLumitex, Inc.1991-12-24

Legacy Summary#

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FDA Review#

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