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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 K952213
Device Name ALCON SERIES 20000 LEGACY PHACOEMULSIFIER
Applicant
Alcon Laboratories
P.O. Box 289 4218 Howard Ave.
Kensington,  MD  20795
Applicant Contact DAVID KRAPF
Correspondent
Alcon Laboratories
P.O. Box 289 4218 Howard Ave.
Kensington,  MD  20795
Correspondent Contact DAVID KRAPF
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/11/1995
Decision Date 08/09/1995
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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