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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Restorative And Impression Material
510(k) Number K770941
Device Name APPLIC SYSTEM ACTIVATOR, ESPE
Applicant
Espe GmbH (Us)
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Espe GmbH (Us)
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4565
Classification Product Code
EID  
Date Received05/23/1977
Decision Date 06/02/1977
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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