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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name graft insertion instrument for endothelial keratoplasty
510(k) Number K121579
Device Name EK DELIVERY DEVICE
Applicant
TDAK MEDICAL, INC
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
TDAK MEDICAL, INC
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number886.4300
Classification Product Code
OTZ  
Date Received05/30/2012
Decision Date 10/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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