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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 K852424
Device Name ACUFEX COMPARATIVE SURGICAL KERATOMETER
Applicant
Acufex Microsurgical, Inc.
575 University Ave.
Norwood,  MA  02062
Applicant Contact WILLIAM RICHARDS
Correspondent
Acufex Microsurgical, Inc.
575 University Ave.
Norwood,  MA  02062
Correspondent Contact WILLIAM RICHARDS
Regulation Number886.1450
Classification Product Code
HJB  
Date Received06/07/1985
Decision Date 09/11/1985
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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