SUOENA AFFINITY (TM) MODEL #802

Prosthesis, Breast, External, Used With Adhesive

COLOPLAST CORP.

The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Suoena Affinity (tm) Model #802.

Pre-market Notification Details

Device IDK921535
510k NumberK921535
Device Name:SUOENA AFFINITY (TM) MODEL #802
ClassificationProsthesis, Breast, External, Used With Adhesive
Applicant COLOPLAST CORP. 2150 NEW MARKET PARKWAY, SUITE 116 Marietta,  GA  30067
ContactLee Lewis
CorrespondentLee Lewis
COLOPLAST CORP. 2150 NEW MARKET PARKWAY, SUITE 116 Marietta,  GA  30067
Product CodeKCZ  
CFR Regulation Number878.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-31
Decision Date1992-05-11

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