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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, operative dental
510(k) Number K992195
Device Name QUANTEC-E IRRIGATION SYSTEM 2
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/29/1999
Decision Date 10/08/1999
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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