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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K861013
Device Name ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
Applicant
Ameritek, Inc.
9805 SW 132nd Ct.
Miami,  FL  33186
Applicant Contact ROBERT GALAN
Correspondent
Ameritek, Inc.
9805 SW 132nd Ct.
Miami,  FL  33186
Correspondent Contact ROBERT GALAN
Regulation Number886.4360
Classification Product Code
KYG  
Date Received03/18/1986
Decision Date 03/31/1986
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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