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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 K890910
Device Name PLAKOF
Applicant
Ximex, Ltd.
63 Lowther Rd.
Barnes, London
England Sw13 9nt,  GB
Applicant Contact SALAM
Correspondent
Ximex, Ltd.
63 Lowther Rd.
Barnes, London
England Sw13 9nt,  GB
Correspondent Contact SALAM
Regulation Number872.6650
Classification Product Code
JET  
Date Received02/23/1989
Decision Date 03/16/1989
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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