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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 K140290
Device Name STOPLOSS JONES TUBE
Applicant
Ljt Surgical, Ltd.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER, JD, RAC
Correspondent
Ljt Surgical, Ltd.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER, JD, RAC
Classification Product Code
OKS  
Date Received02/05/2014
Decision Date 12/02/2014
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
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