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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 K981554
Device Name MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
Applicant
MICRA INSTRUMENTS LTD.
52 BILTON WAY
LUTON,  GB LU1 1UU
Applicant Contact JOHN A.K. BASKERVILLE
Correspondent
MICRA INSTRUMENTS LTD.
52 BILTON WAY
LUTON,  GB LU1 1UU
Correspondent Contact JOHN A.K. BASKERVILLE
Regulation Number886.4370
Classification Product Code
HNO  
Date Received05/01/1998
Decision Date 12/22/1998
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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