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510(k) K852126

Device
ATF 101 TRAIL FRAME
Applicant
ASCON MEDICAL INSTRUMENTS, LTD.
510(k) number
K852126
Product code
HPA  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-05
Date received
1985-05-15
Regulation
886.1415
Classification name
Frame, Trial, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RAVI NALLAKRISHNAN
Address
825 N. Cass Ave., Suite 208 Westmont IL US 60559 60559

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HPA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K852548ATL 225 MW TRAIL LENS SETAscon Medical Instruments, Ltd.1985-07-31
K841768WOODLYN LIGHTWEIGHT TRIAL FRAMEWoodlyn, Inc.1984-06-01
K833669IMAGE DEFLECTORMichael Onufryk1984-03-27
K821084UNIVERSAL TRIAL FRAMEEMedical Equipment Designs, Inc.1982-06-14

Legacy Summary#

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FDA Review#

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