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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Punctum
510(k) Number K140026
Device Name COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
Applicant
Lacrimedics, Inc.
2620 Williamson Pl. NW Suite 113
Du Pont,  WA  98327
Applicant Contact REBECCA DUTTON
Correspondent
Lacrimedics, Inc.
2620 Williamson Pl. NW Suite 113
Du Pont,  WA  98327
Correspondent Contact REBECCA DUTTON
Classification Product Code
LZU  
Date Received01/06/2014
Decision Date 06/03/2014
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
Recalls CDRH Recalls
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