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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hook, Ophthalmic
510(k) Number K030471
Device Name OPHTEC ENCLAVATION NEEDLE
Applicant
Ophtec, USA
6421 Congress Ave., Suite 112
Boca Raton,  FL  33487
Applicant Contact RICK MCCARLEY
Correspondent
Ophtec, USA
6421 Congress Ave., Suite 112
Boca Raton,  FL  33487
Correspondent Contact RICK MCCARLEY
Regulation Number886.4350
Classification Product Code
HNQ  
Date Received02/12/2003
Decision Date 04/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
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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