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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Measuring, Corneal Radius
510(k) Number K930444
Device Name MARCO STANDARD KERATOMETERS
Applicant
Marco Ophthalmic, Inc.
11825 Central Pkwy.
Jacksonville,  FL  32224
Applicant Contact WAYNE STARLING
Correspondent
Marco Ophthalmic, Inc.
11825 Central Pkwy.
Jacksonville,  FL  32224
Correspondent Contact WAYNE STARLING
Regulation Number886.1450
Classification Product Code
HJB  
Date Received01/26/1993
Decision Date 08/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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