BAYERS BIMANUAL I/A HANDPIECES

Unit, Phacofragmentation

VISION CARE DEVICES, INC.

The following data is part of a premarket notification filed by Vision Care Devices, Inc. with the FDA for Bayers Bimanual I/a Handpieces.

Pre-market Notification Details

Device IDK971064
510k NumberK971064
Device Name:BAYERS BIMANUAL I/A HANDPIECES
ClassificationUnit, Phacofragmentation
Applicant VISION CARE DEVICES, INC. 1246 REDWOOD BLVD. Redding,  CA  96003
ContactChet Cracchiolo
CorrespondentChet Cracchiolo
VISION CARE DEVICES, INC. 1246 REDWOOD BLVD. Redding,  CA  96003
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-24
Decision Date1997-06-09

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