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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
510(k) Number K926517
Device Name ELMED LBC 50-P
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 Number884.4150
Classification Product Code
HIN  
Date Received12/30/1992
Decision Date 11/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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