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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 K874334
Device Name SOLOS SINGLE USE TITANIUM TIP
Applicant
Solos Ophthalmology
6191 Atlantic Blvd.
Norcross,  GA  30071
Applicant Contact STEPHEN HOLMES
Correspondent
Solos Ophthalmology
6191 Atlantic Blvd.
Norcross,  GA  30071
Correspondent Contact STEPHEN HOLMES
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/22/1987
Decision Date 01/11/1988
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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