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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 K140352
Device Name VERAPLUG
Applicant
Krishna Imports Inc Dba Stephens Instruments
2500 Sandersville Rd.
Lexington,  KY  40511
Applicant Contact ARCHNA JOHNSON
Correspondent
Krishna Imports Inc Dba Stephens Instruments
2500 Sandersville Rd.
Lexington,  KY  40511
Correspondent Contact ARCHNA JOHNSON
Classification Product Code
LZU  
Date Received02/12/2014
Decision Date 11/13/2014
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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