Product code KCZ— General, Plastic Surgery

FDA has cleared 13 devices under product code KCZ between 1989 and 1999, filed by 10 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19991 clearance
• 19951 clearance
• 19941 clearance
• 19933 clearances
• 19922 clearances
• 19911 clearance
• 19903 clearances
• 19891 clearance

• Coloplast Corp.3 clearances
• Coloplast A/S2 clearances
• Straumann USA1 clearance
• Spenco Medical Corp.1 clearance
• Maxol Limited L.C.1 clearance
• Jobst Institute, Inc.1 clearance
• Hemispheres Marketing Co. , Ltd.1 clearance
• Great Bay Medical Products, Inc.1 clearance
• Dekumed, Kunststofftechnik Degler GmbH1 clearance
• Almost U., Inc.1 clearance

• K990458 — STRAUMANN EXTRAORAL IMPLANT SYSTEMStraumann USA·1999-04-16
• K951324 — MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESISMaxol Limited L.C.·1995-05-26
• K933465 — COSMETGreat Bay Medical Products, Inc.·1994-07-20
• K932978 — CALSSIQUE OR MYSTIQUEDekumed, Kunststofftechnik Degler GmbH·1993-12-22
• K932899 — CLASSIQUEHemispheres Marketing Co. , Ltd.·1993-12-16
• K933668 — ALMOST U, INC. BREAST PROSTHESISAlmost U., Inc.·1993-12-10
• K921535 — SUOENA AFFINITY (TM) MODEL #802Coloplast Corp.·1992-05-11
• K915382 — AMOENA AFFINITY MODEL #802Coloplast Corp.·1992-01-14
• K911247 — YOURS TRULY ASYMMETRICAL BREAST FORMJobst Institute, Inc.·1991-03-29
• K904085 — ELLA BREAST FORMColoplast A/S·1990-10-31
• K904316 — NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHTColoplast Corp.·1990-10-11
• K904086 — DISCRENE SELF-SUPPORTING BREAST FORMColoplast A/S·1990-10-02
• K896533 — SPENCO BREAST FORMSSpenco Medical Corp.·1989-12-13