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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 K925027
Device Name PHOTAC-FIL APLICAP
Applicant
Espe GmbH (Us)
Fabrik Pharmazeutischer
D-8031 Seefeld/Oberbay
West Germany,  DE
Applicant Contact ANTJE BRECHENMACHER
Correspondent
Espe GmbH (Us)
Fabrik Pharmazeutischer
D-8031 Seefeld/Oberbay
West Germany,  DE
Correspondent Contact ANTJE BRECHENMACHER
Regulation Number872.3275
Classification Product Code
EMA  
Date Received10/02/1992
Decision Date 06/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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