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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 K113316
Device Name DCS LACRIMAL STENT
Applicant
DCS SURGICAL INC
1110 LINDEN AVE.
BOULDER,  CO  80304
Applicant Contact HARRY ROSS
Correspondent
DCS SURGICAL INC
1110 LINDEN AVE.
BOULDER,  CO  80304
Correspondent Contact HARRY ROSS
Classification Product Code
OKS  
Date Received11/09/2011
Decision Date 11/08/2012
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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