COVAMAX RESORBABLE COLLAGEN MEMBRANE— 510(k) K103087

Name: FDA 510(k) clearance K103087
Creator: U.S. Food and Drug Administration
Published: 2011-08-26

Substantially Equivalent

Biom'Up Sas

FDA 510(k) clearance K103087 for COVAMAX RESORBABLE COLLAGEN MEMBRANE, Substantially Equivalent on 2011-08-26. Applicant: Biom'Up Sas. Device class: 2.

Clearance details

Applicant: Biom'Up Sas
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-10-19
Decision date: 2011-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St-Priest, FR

Download summary PDF View on FDA.gov ↗

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Recalls naming K103087

K-number listed on FDA's recall record

Z-1110-2017 — RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.Class II·Terminated·Biom'up·20161202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103087.

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