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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
510(k) Number K990908
Device Name MILLENNIUM
Applicant
ENDO TECHNIC CORP.
981 CALLE AMANECER
(MOVED FROM BOS/DO TO LA/DOS)
SAN CLEMENTE,  CA  92673 -6212
Applicant Contact ANDREW I KIMMEL
Correspondent
ENDO TECHNIC CORP.
981 CALLE AMANECER
(MOVED FROM BOS/DO TO LA/DOS)
SAN CLEMENTE,  CA  92673 -6212
Correspondent Contact ANDREW I KIMMEL
Regulation Number872.4120
Classification Product Code
MXF  
Date Received03/18/1999
Decision Date 05/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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