ELLA BREAST FORM

Prosthesis, Breast, External, Used With Adhesive

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Ella Breast Form.

Pre-market Notification Details

Device IDK904085
510k NumberK904085
Device Name:ELLA BREAST FORM
ClassificationProsthesis, Breast, External, Used With Adhesive
Applicant COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth,  TX  76162
ContactRichard A Hamer
CorrespondentRichard A Hamer
COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth,  TX  76162
Product CodeKCZ  
CFR Regulation Number878.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-05
Decision Date1990-10-31

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