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510(k) K830335

Device
DORC CORNEAL PUNCH BLOCK
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K830335
Product code
HNJ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-09
Date received
1983-02-01
Regulation
886.4350
Classification name
Punch, Corneo-scleral
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871646TANNE CORNEAL CUTTING BLOCKOcular Instruments, Inc.1987-05-18
K791988REPL. PISTON FOR TROUTMAN CORNEAL PUNCHEdward Weck, Inc.1979-10-30

Legacy Summary#

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FDA Review#

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