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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
510(k) Number K043035
Device Name SEPRAGEL ENT BIORESORBABLE PACKING/STENT
Applicant
Genzyme Corporation
55 Cambridge Pkwy.
Cambridge,  MA  02142
Applicant Contact BARBARA PIZZA
Correspondent
Genzyme Corporation
55 Cambridge Pkwy.
Cambridge,  MA  02142
Correspondent Contact BARBARA PIZZA
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received11/03/2004
Decision Date 07/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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