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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 K896532
Device Name DENTAL DELIVERY SYSTEM
Applicant
Dentech Corp.
P.O. Box 157
529 W. Front St.
Sumas,  WA  98295
Applicant Contact AL KENNEDY
Correspondent
Dentech Corp.
P.O. Box 157
529 W. Front St.
Sumas,  WA  98295
Correspondent Contact AL KENNEDY
Regulation Number872.6640
Classification Product Code
EIA  
Date Received11/14/1989
Decision Date 02/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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