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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pick, Massaging
510(k) Number K885189
Device Name MASSAGING PICK FOR ORAL HYGIENE
Applicant
Dentek Corp.
32 Leveroni Ct.
Suite 101
Novato,  CA  94949
Applicant Contact JOHN M JANSHESKI
Correspondent
Dentek Corp.
32 Leveroni Ct.
Suite 101
Novato,  CA  94949
Correspondent Contact JOHN M JANSHESKI
Regulation Number872.6650
Classification Product Code
JET  
Date Received12/16/1988
Decision Date 03/17/1989
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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