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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K882399
Device Name ASEPTIP
Applicant
Koppa Innovative Dental Products, Inc.
N-2703 Spotted Rd.
Spokane,  WA  99204
Applicant Contact ROBERT J KOPPA
Correspondent
Koppa Innovative Dental Products, Inc.
N-2703 Spotted Rd.
Spokane,  WA  99204
Correspondent Contact ROBERT J KOPPA
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received06/10/1988
Decision Date 06/21/1988
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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