ZENIEVA— 510(k) K073246

Substantially Equivalent

Gorbec Pharmaceutical Services, Inc.

FDA 510(k) clearance K073246 for ZENIEVA, Substantially Equivalent on 2008-07-23. Applicant: Gorbec Pharmaceutical Services, Inc.. Device class: 1.

Clearance details

Applicant: Gorbec Pharmaceutical Services, Inc.
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 2007-11-19
Decision date: 2008-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NAE

K083721 — MODIFICATION TO ZENIEVA2009-01-08
K082865 — MODIFICATION TO ZENIEVA2008-10-23
K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING1999-09-17
K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING1999-06-28
K972646 — AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES1997-08-21

More clearances from Gorbec Pharmaceutical Services, Inc.

K100839 — BARIREP2010-05-11

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