KCZ · Class I · 21 CFR 878.3800

FDA Product Code KCZ: Prosthesis, Breast, External, Used With Adhesive

Leading manufacturers include Coloplast Corp., Coloplast A/S and Straumann USA.

13
Total
13
Cleared
95d
Avg days
1989
Since

FDA 510(k) Cleared Prosthesis, Breast, External, Used With Adhesive Devices (Product Code KCZ)

13 devices
1–13 of 13
Cleared Apr 16, 1999
STRAUMANN EXTRAORAL IMPLANT SYSTEM
K990458
Straumann USA
General & Plastic Surgery · 63d
Cleared May 11, 1992
SUOENA AFFINITY (TM) MODEL #802
K921535
Coloplast Corp.
General & Plastic Surgery · 41d
Cleared Jan 14, 1992
AMOENA AFFINITY MODEL #802
K915382
Coloplast Corp.
General & Plastic Surgery · 46d
Cleared Oct 31, 1990
ELLA BREAST FORM
K904085
Coloplast A/S
General & Plastic Surgery · 56d
Cleared Oct 11, 1990
NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
K904316
Coloplast Corp.
General & Plastic Surgery · 20d
Cleared Oct 02, 1990
DISCRENE SELF-SUPPORTING BREAST FORM
K904086
Coloplast A/S
General & Plastic Surgery · 27d

About Product Code KCZ - Regulatory Context