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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Corneal
510(k) Number K913239
Device Name GOLDLENS(TM)
Applicant
Doran Instruments, Inc.
410 Great Rd.
P.O. Box 1070
Littleton,  MA  01460
Applicant Contact BRUCE DORAN
Correspondent
Doran Instruments, Inc.
410 Great Rd.
P.O. Box 1070
Littleton,  MA  01460
Correspondent Contact BRUCE DORAN
Regulation Number886.1220
Classification Product Code
HLZ  
Date Received07/22/1991
Decision Date 01/31/1992
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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