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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 K950799
Device Name PRO-VIT
Applicant
M. Imonti and Associates Inc.,
25707 Compass Way
San Juan Capistrano,  CA  92675
Applicant Contact MAURICE IMONTI
Correspondent
M. Imonti and Associates Inc.,
25707 Compass Way
San Juan Capistrano,  CA  92675
Correspondent Contact MAURICE IMONTI
Regulation Number886.4150
Classification Product Code
HQE  
Date Received02/21/1995
Decision Date 04/28/1995
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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