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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 K981103
Device Name TURBOSONICS LIMITED REUSE ULTRASONIC TIP
Applicant
Alcon Laboratories
6201 S. Freeway, R7-14
Fort Worth,  TX  76134 -2099
Applicant Contact MARTIN A KAUFMAN
Correspondent
Alcon Laboratories
6201 S. Freeway, R7-14
Fort Worth,  TX  76134 -2099
Correspondent Contact MARTIN A KAUFMAN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/26/1998
Decision Date 06/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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