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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 SOUTH FREEWAY
R7-14
FORT WORTH,  TX  76134 -2099
Applicant Contact MARTIN A KAUFMAN
Correspondent
ALCON LABORATORIES
6201 SOUTH 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
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