NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT— 510(k) K904316

Name: FDA 510(k) clearance K904316
Creator: U.S. Food and Drug Administration
Published: 1990-10-11

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K904316 for NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT, Substantially Equivalent on 1990-10-11. Applicant: Coloplast Corp.. Device class: 1.

Clearance details

Applicant: Coloplast Corp.
Product code: Code KCZ
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1990-09-21
Decision date: 1990-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCZ

view all

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

More clearances from Coloplast Corp.

view all

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