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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 K192418
Device Name Phacoemulsification Needle (Tip) and Irrigation Sleeve
Applicant
Raico LLC
26 Plaza Dr
Westmont,  IL  60559
Applicant Contact Ravi Nallakrishnan
Correspondent
Raico LLC
26 Plaza Dr
Westmont,  IL  60559
Correspondent Contact Ravi Nallakrishnan
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/04/2019
Decision Date 05/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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