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FDA 510(k) Application Details - K990908
Device Classification Name
System,Dental,Hydrokinetic,Carries Removal & Cavity Preparation
More FDA Info for this Device
510(K) Number
K990908
Device Name
System,Dental,Hydrokinetic,Carries Removal & Cavity Preparation
Applicant
ENDO TECHNIC CORP.
981 CALLE AMANECER
(MOVED FROM BOS/DO TO LA/DOS)
SAN CLEMENTE, CA 92673-6212 US
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Contact
ANDREW I KIMMEL
Other 510(k) Applications for this Contact
Regulation Number
872.4120
More FDA Info for this Regulation Number
Classification Product Code
MXF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/18/1999
Decision Date
05/27/1999
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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