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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K010465
Device Name DENSTAT
Applicant
Elmed, Inc.
60 W. Fay Ave.
Addison,  IL  60101
Applicant Contact WERNER HAUSNER
Correspondent
Elmed, Inc.
60 W. Fay Ave.
Addison,  IL  60101
Correspondent Contact WERNER HAUSNER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/16/2001
Decision Date 05/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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