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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lacrimal Stents And Intubation Sets
510(k) Number K120886
Device Name LACRIFAST
Applicant
Hiroyasu Higuchi
4-1 17 Hongo, Bunkyo-Ku
Tokyo,  JP 113-0033
Applicant Contact FUMIAKI KANAI, PH.D.
Correspondent
Hiroyasu Higuchi
4-1 17 Hongo, Bunkyo-Ku
Tokyo,  JP 113-0033
Correspondent Contact FUMIAKI KANAI, PH.D.
Classification Product Code
OKS  
Date Received03/23/2012
Decision Date 12/17/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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