TURBOSONICS LIMITED REUSE ULTRASONIC TIP

Unit, Phacofragmentation

ALCON LABORATORIES

The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Turbosonics Limited Reuse Ultrasonic Tip.

Pre-market Notification Details

Device IDK981103
510k NumberK981103
Device Name:TURBOSONICS LIMITED REUSE ULTRASONIC TIP
ClassificationUnit, Phacofragmentation
Applicant ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
ContactMartin A Kaufman
CorrespondentMartin A Kaufman
ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-26
Decision Date1998-06-23
Summary:summary

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