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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K864226
Device Name JOHNSON & JOHNSON STAINING REMOVING COMPOUND
Applicant
Johnson & Johnson Professionals, Inc.
20 Lake Dr.
Cn 7060
East Windsor,  NJ  08520
Applicant Contact CAROL E LANDSMAN
Correspondent
Johnson & Johnson Professionals, Inc.
20 Lake Dr.
Cn 7060
East Windsor,  NJ  08520
Correspondent Contact CAROL E LANDSMAN
Regulation Number872.6030
Classification Product Code
EJR  
Date Received10/28/1986
Decision Date 05/01/1987
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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