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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Ear, Nose And Throat
510(k) Number K080032
Device Name ENVOYCEM, MODEL 1640
Applicant
Envoy Medical Corporation
5000 Township Pkwy.
St. Paul,  MN  55110
Applicant Contact BERNARD (BUD) HORWATH
Correspondent
Envoy Medical Corporation
5000 Township Pkwy.
St. Paul,  MN  55110
Correspondent Contact BERNARD (BUD) HORWATH
Regulation Number872.3275
Classification Product Code
NEA  
Date Received01/07/2008
Decision Date 02/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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