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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name magnet, permanent
510(k) Number K860960
Device Name RARE EARTH INTRA-OCULAR MAGNET
Applicant
AMERITEK, INC.
9805 S.W. 132nd Court
Miami,  FL  33186
Applicant Contact ROBERT GALAN
Correspondent
AMERITEK, INC.
9805 S.W. 132nd Court
Miami,  FL  33186
Correspondent Contact ROBERT GALAN
Regulation Number886.4445
Classification Product Code
HPN  
Date Received03/13/1986
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
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