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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 K871879
Device Name SOFSWAB
Applicant
Plastic Engineered Products Co.
800 Savannah Ave. NE
Canton,  OH  44704
Applicant Contact CHARLES P THOMPSON
Correspondent
Plastic Engineered Products Co.
800 Savannah Ave. NE
Canton,  OH  44704
Correspondent Contact CHARLES P THOMPSON
Regulation Number872.6855
Classification Product Code
EFW  
Date Received05/14/1987
Decision Date 07/28/1987
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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