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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 K860891
Device Name AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE
Applicant
Intra-Optics Labs. C/O Newman Assoc.
25283 Cabot Rd., Suite 207
Laguna Hills,  CA  92653
Applicant Contact CHARLES H NEWMAN
Correspondent
Intra-Optics Labs. C/O Newman Assoc.
25283 Cabot Rd., Suite 207
Laguna Hills,  CA  92653
Correspondent Contact CHARLES H NEWMAN
Regulation Number886.4150
Classification Product Code
HQE  
Date Received03/10/1986
Decision Date 04/21/1986
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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