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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Manual
510(k) Number K901994
Device Name ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM
Applicant
Rosofsky & Ross, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Applicant Contact B DUBECK
Correspondent
Rosofsky & Ross, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Correspondent Contact B DUBECK
Regulation Number872.6855
Classification Product Code
EFW  
Date Received05/02/1990
Decision Date 07/31/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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