SEPRAGEL ENT BIORESORBABLE PACKING/STENT— 510(k) K043035

Name: FDA 510(k) clearance K043035
Creator: U.S. Food and Drug Administration
Published: 2005-07-11

Substantially Equivalent

Genzyme Corporation

FDA 510(k) clearance K043035 for SEPRAGEL ENT BIORESORBABLE PACKING/STENT, Substantially Equivalent on 2005-07-11. Applicant: Genzyme Corporation. Device class: 2.

Clearance details

Applicant: Genzyme Corporation
Product code: Code KHJ
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2004-11-03
Decision date: 2005-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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