Cleared Traditional

SEPRAGEL ENT BIORESORBABLE PACKING/STENT

K043035 · Genzyme Corporation · Ear, Nose, Throat
Jul 2005
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K043035 is an FDA 510(k) clearance for the SEPRAGEL ENT BIORESORBABLE PACKING/STENT, a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ), submitted by Genzyme Corporation (Cambridge, US). The FDA issued a Cleared decision on July 11, 2005, 250 days after receiving the submission on November 3, 2004. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K043035 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2004
Decision Date July 11, 2005
Days to Decision 250 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KHJ — Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3620

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