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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 K030300
Device Name OPAQUE HERRICK LACRIMAL PLUG
Applicant
Lacrimedics, Inc.
310 Prune Aly.
Eastsound,  WA  98245
Applicant Contact JERRY HENDERSON
Correspondent
Lacrimedics, Inc.
310 Prune Aly.
Eastsound,  WA  98245
Correspondent Contact JERRY HENDERSON
Classification Product Code
LZU  
Date Received01/29/2003
Decision Date 05/09/2003
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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