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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 K901806
Device Name SUCTION ORA-SWAB(R) BRUSH KIT
Applicant
Sage Products, Inc.
680 Industrial Dr.
Cary,  IL  60013
Applicant Contact PAUL HANIFL
Correspondent
Sage Products, Inc.
680 Industrial Dr.
Cary,  IL  60013
Correspondent Contact PAUL HANIFL
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/20/1990
Decision Date 08/15/1990
Decision Substantially Equivalent - With Drug (SESD)
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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