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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, Bedfordshire,  GB LU1 1UU
Applicant Contact JOHN A.K. BASKERVILLE
Correspondent
Micra Instruments , Ltd.
52 Bilton Way,
Luton, Bedfordshire,  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
Predetermined Change
Control Plan Authorized		 No
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