PIEZO HANDPIECE

Unit, Phacofragmentation

UNITED SURGICAL CORP.

The following data is part of a premarket notification filed by United Surgical Corp. with the FDA for Piezo Handpiece.

Pre-market Notification Details

Device IDK902150
510k NumberK902150
Device Name:PIEZO HANDPIECE
ClassificationUnit, Phacofragmentation
Applicant UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine,  CA  92718
ContactDan Brostoff
CorrespondentDan Brostoff
UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine,  CA  92718
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-15
Decision Date1990-07-05

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