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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name injector, capsular tension ring
510(k) Number K011498
Device Name EASY CONTROL MICRO INSERTER, MODEL ON385
Applicant
OPHTEC USA, INC.
6421 CONGRESS AVE., SUITE 112
BOCA RATON,  FL  33487
Applicant Contact RICK MCCARLEY
Correspondent
OPHTEC USA, INC.
6421 CONGRESS AVE., SUITE 112
BOCA RATON,  FL  33487
Correspondent Contact RICK MCCARLEY
Regulation Number886.4300
Classification Product Code
NCE  
Date Received05/15/2001
Decision Date 07/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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