NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT

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 Nouvelle (tm) Model #901, Sizes 0-12, Left & Right.

Pre-market Notification Details

Device IDK904316
510k NumberK904316
Device Name:NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
ClassificationProsthesis, Breast, External, Used With Adhesive
Applicant COLOPLAST CORP. 2150 NEW MARKET PARKWAY, SUITE 116 Marietta,  GA  30067
ContactTracy L Sadowski
CorrespondentTracy L Sadowski
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 Received1990-09-21
Decision Date1990-10-11

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