510(k) K102999

Device: TRIMOTION INJECTOR
Applicant: KANEKA CORP.
510(k) number: K102999
Product code: OTZ
Decision: Substantially Equivalent (SESE)
Decision date: 2011-12-29
Date received: 2010-10-08
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: TAMIJI FUJIMOTO
Address: 5-1-1, Torikai-Nishi Settsu, Osaka JP 566-0072 566-0072

FDA Registration Numbers#

3005357288
3004571672
3027553380
1036836
2029275

Source Documents#

Other 510(k) Records For Product Code OTZ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K203586	EndoSerter-PL	Corneagen, Inc.	2022-02-02
K121579	EK DELIVERY DEVICE	Tdak Medical, Inc.	2012-10-03
K110734	NCI SPATULA	Fischer Surgical, Inc.	2012-05-31
K090626	ENDOSERTER	Ocular Systems, Inc.	2011-01-21

Legacy Summary#

summary

FDA Review#

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