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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 K973294
Device Name INNOVATOME MICROKERATOME
Applicant
INNOVATIVE OPTICS, INC.
4307 CEDARWOOD DR.
LILBURN,  GA  30247
Applicant Contact LARRY HICKS
Correspondent
INNOVATIVE OPTICS, INC.
4307 CEDARWOOD DR.
LILBURN,  GA  30247
Correspondent Contact LARRY HICKS
Regulation Number886.4370
Classification Product Code
HNO  
Subsequent Product Code
HMY  
Date Received09/02/1997
Decision Date 10/03/1997
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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