FDA 510(k) Application Details - K990908

Device Classification Name System,Dental,Hydrokinetic,Carries Removal & Cavity Preparation

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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
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Regulation Number 872.4120

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Classification Product Code MXF
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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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