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FDA 510(k) Application Details - K004031
Device Classification Name
File, Pulp Canal, Endodontic
More FDA Info for this Device
510(K) Number
K004031
Device Name
File, Pulp Canal, Endodontic
Applicant
DENTAL POWER, INC.
24422 DEL PRADO
# 11
DANA POINT, CA 92629 US
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Contact
JOHN SCHOEFFEL
Other 510(k) Applications for this Contact
Regulation Number
872.4565
More FDA Info for this Regulation Number
Classification Product Code
EKS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/28/2000
Decision Date
03/28/2001
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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