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510(k) K110734

Device
NCI SPATULA
Applicant
FISCHER SURGICAL INC.
510(k) number
K110734
Product code
OTZ  
Decision
Substantially Equivalent (SESE)
Decision date
2012-05-31
Date received
2011-03-16
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
JESSICA DIXON
Address
1012 Palmer Ln., Suite 200 Imperial MO US 63052 63052

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OTZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203586EndoSerter-PLCorneagen, Inc.2022-02-02
K121579EK DELIVERY DEVICETdak Medical, Inc.2012-10-03
K102999TRIMOTION INJECTORKaneka Corp.2011-12-29
K090626ENDOSERTEROcular Systems, Inc.2011-01-21

Legacy Summary#

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FDA Review#

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