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 Almost U., Inc..

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 26, 1995
MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS
K951324
Maxol Limited L.C.
General & Plastic Surgery · 64d
Cleared Jul 20, 1994
COSMET
K933465
Great Bay Medical Products, Inc.
General & Plastic Surgery · 369d
Cleared Dec 22, 1993
CALSSIQUE OR MYSTIQUE
K932978
Dekumed, Kunststofftechnik Degler GmbH
General & Plastic Surgery · 188d
Cleared Dec 16, 1993
CLASSIQUE
K932899
Hemispheres Marketing Co. , Ltd.
General & Plastic Surgery · 185d
Cleared Dec 10, 1993
ALMOST U, INC. BREAST PROSTHESIS
K933668
Almost U., Inc.
General & Plastic Surgery · 135d
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 Mar 29, 1991
YOURS TRULY ASYMMETRICAL BREAST FORM
K911247
Jobst Institute, Inc.
General & Plastic Surgery · 8d
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
Cleared Dec 13, 1989
SPENCO BREAST FORMS
K896533
Spenco Medical Corp.
General & Plastic Surgery · 29d

About Product Code KCZ - Regulatory Context