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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ear, Nose And Throat, Synthetic, Absorbable
510(k) Number K070886
Device Name MEROGEL INJECTABLE BIORESORBABLE STENT
Applicant
Medtronic, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32259
Applicant Contact JAYME WILSON
Correspondent
Medtronic, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32259
Correspondent Contact JAYME WILSON
Regulation Number874.3620
Classification Product Code
NHB  
Date Received03/30/2007
Decision Date 04/26/2007
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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