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510(k) K203586

Device
EndoSerter-PL
Applicant
CorneaGen, Inc
510(k) number
K203586
Product code
OTZ  
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-02
Date received
2020-12-08
Regulation
886.4300
Classification name
Graft Insertion Instrument For Endothelial Keratoplasty
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tom Miller
Address
101 N. Chestnut St. Suite 303 Winston-Salem NC US 27101 27101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OTZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121579EK DELIVERY DEVICETdak Medical, Inc.2012-10-03
K110734NCI SPATULAFischer Surgical, Inc.2012-05-31
K102999TRIMOTION INJECTORKaneka Corp.2011-12-29
K090626ENDOSERTEROcular Systems, Inc.2011-01-21

Legacy Summary#

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FDA Review#

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