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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Engine, Trephine, Accessories, Ac-Powered
510(k) Number K791763
Device Name (MICRO-KERATRON, MICRO DUCT TREPHINE)
Applicant
Intl. Ophthalmic Industries Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Intl. Ophthalmic Industries Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4070
Classification Product Code
HRG  
Date Received09/05/1979
Decision Date 11/05/1979
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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