CLASSIQUE— 510(k) K932899

Substantially Equivalent

Hemispheres Marketing Co. , Ltd.

FDA 510(k) clearance K932899 for CLASSIQUE, Substantially Equivalent on 1993-12-16. Applicant: Hemispheres Marketing Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Hemispheres Marketing Co. , Ltd.
Product code: Code KCZ
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1993-06-14
Decision date: 1993-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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
K933668 — ALMOST U, INC. BREAST PROSTHESIS1993-12-10

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