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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Fluoride, Disposable
510(k) Number K820104
Device Name NUPRO* GEL TRAY
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Regulation Number872.6870
Classification Product Code
KMT  
Date Received01/15/1982
Decision Date 02/23/1982
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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