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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 K904085
Device Name ELLA BREAST FORM
Applicant
COLOPLAST A/S
C/O RICHARD HAMER ASSOC., INC.
P.O. BOX 16598
FT. WORTH,  TX  76162
Applicant Contact RICHARD A HAMER
Correspondent
COLOPLAST A/S
C/O RICHARD HAMER ASSOC., INC.
P.O. BOX 16598
FT. WORTH,  TX  76162
Correspondent Contact RICHARD A HAMER
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received09/05/1990
Decision Date 10/31/1990
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
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