MENTOR STERILE SALINE MAMMARY VOLUME SIZERS

Sizer, Mammary, Breast Implant Volume

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Sterile Saline Mammary Volume Sizers.

Pre-market Notification Details

Device IDK010709
510k NumberK010709
Device Name:MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
ClassificationSizer, Mammary, Breast Implant Volume
Applicant MENTOR CORP. 201 MENTOR DR. Santa Barbara,  CA  93111
ContactDonna Crawford
CorrespondentDonna Crawford
MENTOR CORP. 201 MENTOR DR. Santa Barbara,  CA  93111
Product CodeMRD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-09
Decision Date2001-04-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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