ELLA BREAST FORM— 510(k) K904085

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K904085 for ELLA BREAST FORM, Substantially Equivalent on 1990-10-31. Applicant: Coloplast A/S. Device class: 1.

Clearance details

Applicant: Coloplast A/S
Product code: Code KCZ
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1990-09-05
Decision date: 1990-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Woth, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCZ

K990458 — STRAUMANN EXTRAORAL IMPLANT SYSTEM1999-04-16
K951324 — MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS1995-05-26
K933465 — COSMET1994-07-20
K932978 — CALSSIQUE OR MYSTIQUE1993-12-22
K932899 — CLASSIQUE1993-12-16

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Data sourced from openFDA. This site is unofficial and independent of the FDA.