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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Ac-Powered
510(k) Number K983317
Device Name BARRON MICROKERATOME SYSTEM, MODEL B2000
Applicant
Barron Precision Instruments, LLC
P.O. Box 973, 8170 Embury Rd.
Grand Blanc,  MI  48439
Applicant Contact MARK BARRON
Correspondent
Barron Precision Instruments, LLC
P.O. Box 973, 8170 Embury Rd.
Grand Blanc,  MI  48439
Correspondent Contact MARK BARRON
Regulation Number886.4370
Classification Product Code
HNO  
Date Received09/21/1998
Decision Date 12/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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