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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K933627
Device Name PHACOFRAGMENTOR TIP
Applicant
M. Imonti and Associates Inc.,
25707 Compass Way
San Juan Capistrano,  CA  92675
Correspondent
M. Imonti and Associates Inc.,
25707 Compass Way
San Juan Capistrano,  CA  92675
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/27/1993
Decision Date 01/25/1994
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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