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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 K981989
Device Name THE WAVE DIGITAL PHACO SYSTEM
Applicant
Circuit Tree
25707n Compass Way
San Juan Capistrano,  CA  92675
Applicant Contact MAURICE IMONTI
Correspondent
Circuit Tree
25707n Compass Way
San Juan Capistrano,  CA  92675
Correspondent Contact MAURICE IMONTI
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/05/1998
Decision Date 08/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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