510(k) K121579

Device: EK DELIVERY DEVICE
Applicant: TDAK MEDICAL, INC
510(k) number: K121579
Product code: OTZ
Decision: Substantially Equivalent (SESE)
Decision date: 2012-10-03
Date received: 2012-05-30
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: GREG HOLLAND
Address: 3722 Ave. Sausalito Irvine CA US 92606 92606

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
K110734	NCI SPATULA	Fischer Surgical, Inc.	2012-05-31
K102999	TRIMOTION INJECTOR	Kaneka Corp.	2011-12-29
K090626	ENDOSERTER	Ocular Systems, Inc.	2011-01-21

Legacy Summary#

summary

FDA Review#

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