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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K930438
Device Name MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS
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 Number886.1850
Classification Product Code
HJO  
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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