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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Breast, External, Used With Adhesive
510(k) Number K921535
Device Name SUOENA AFFINITY (TM) MODEL #802
Applicant
Coloplast Corp.
2150 New Market Pkwy.,
Suite 116
Marietta,  GA  30067
Applicant Contact LEE LEWIS
Correspondent
Coloplast Corp.
2150 New Market Pkwy.,
Suite 116
Marietta,  GA  30067
Correspondent Contact LEE LEWIS
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received03/31/1992
Decision Date 05/11/1992
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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