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FDA 510(k) Application Details - K991913
Device Classification Name
Amalgamator, Dental, Ac-Powered
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510(K) Number
K991913
Device Name
Amalgamator, Dental, Ac-Powered
Applicant
ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
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Contact
A. PETERMANN
Other 510(k) Applications for this Contact
Regulation Number
872.3100
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Classification Product Code
EFD
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More FDA Info for this Product Code
Date Received
06/07/1999
Decision Date
07/26/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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