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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K973262
Device Name KETAC-FIL APLICAP PLUS
Applicant
Espe GmbH & Co. Kg.
Am Griesberg 2
Seefeld,  DE D-82229
Applicant Contact BARBARA WAGNER-SCHUH
Correspondent
Espe GmbH & Co. Kg.
Am Griesberg 2
Seefeld,  DE D-82229
Correspondent Contact BARBARA WAGNER-SCHUH
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/29/1997
Decision Date 11/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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