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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, External Aesthetic Restoration, Used With Adhesive
510(k) Number K864785
Device Name AMOENA BREAST FORMS
Applicant
Coloplast Corp.
2150 New Market Pkwy.,
Suite 116
Marietta,  GA  30067
Applicant Contact THOMAS B TAYLOR
Correspondent
Coloplast Corp.
2150 New Market Pkwy.,
Suite 116
Marietta,  GA  30067
Correspondent Contact THOMAS B TAYLOR
Regulation Number878.3800
Classification Product Code
GBI  
Date Received12/08/1986
Decision Date 01/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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