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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 K872611
Device Name SOLOS EYESITE CAP SLEEVE
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 Received07/06/1987
Decision Date 08/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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