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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Powered
510(k) Number K936076
Device Name ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
Applicant
Ohio Health Care Products, Inc.
9024-C Euclid Ave.
Manassas,  VA  22110
Applicant Contact MARTIN J COHEN
Correspondent
Ohio Health Care Products, Inc.
9024-C Euclid Ave.
Manassas,  VA  22110
Correspondent Contact MARTIN J COHEN
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received12/20/1993
Decision Date 01/26/1994
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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