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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K890133
Device Name OCULAR CONNECTION MACHINE(TM)
Applicant
Innovision Medical, Inc.
2532 White Rd.
Irvine,  CA  92714
Applicant Contact GUSTAVUS D BOCK
Correspondent
Innovision Medical, Inc.
2532 White Rd.
Irvine,  CA  92714
Correspondent Contact GUSTAVUS D BOCK
Regulation Number886.4150
Classification Product Code
HQE  
Date Received01/12/1989
Decision Date 04/12/1989
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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