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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, L.L.C.
PO BOX 973, 8170 EMBURY RD.
GRAND BLANC,  MI  48439 -0973
Applicant Contact MARK BARRON
Correspondent
BARRON PRECISION INSTRUMENTS, L.L.C.
PO BOX 973, 8170 EMBURY RD.
GRAND BLANC,  MI  48439 -0973
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
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