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FDA 510(k) Application Details - K984483
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device
510(K) Number
K984483
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
S & C POLYMER GMBH
ROBERT-BOSCH-STR. 5
D-25335
ELMSHORN DE
Other 510(k) Applications for this Company
Contact
JURGEN ENGELBRECHT
Other 510(k) Applications for this Contact
Regulation Number
872.3760
More FDA Info for this Regulation Number
Classification Product Code
EBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/1998
Decision Date
02/18/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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