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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 K160710
Device Name Oasis Lacrimal Intubation Set
Applicant
Anodyne
804 Corporate Centre Dr.
O' Fallon,  MO  63368
Applicant Contact VALERIE ANDERSON
Correspondent
Anodyne
804 Corporate Centre Dr.
O' Fallon,  MO  63368
Correspondent Contact VALERIE ANDERSON
Classification Product Code
OKS  
Date Received03/15/2016
Decision Date 05/13/2016
Decision Substantially Equivalent - Kit (SESK)
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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