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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 K964018
Device Name PHACOILLUMINATOR - FIBEROPTIC SLEEVE
Applicant
MICHAEL REYNARD, M.D.
1301-20TH ST., #260
SANTA MONICA,  CA  90404
Applicant Contact MICHAEL REYNARD
Correspondent
MICHAEL REYNARD, M.D.
1301-20TH ST., #260
SANTA MONICA,  CA  90404
Correspondent Contact MICHAEL REYNARD
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/07/1996
Decision Date 02/26/1997
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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