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FDA 510(k) Application Details - K080195
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K080195
Device Name
Powder, Porcelain
Applicant
DOCERAM MEDICAL CERAMICS GMBH
65-67 HESSLINGSWEG
DORTMUND, NRW D-44309 DE
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Contact
HOLGER WAMPERS
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/25/2008
Decision Date
04/28/2008
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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