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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Floss, Dental
510(k) Number K952091
Device Name VUTLER G.U.M. WITH FLUORIDE
Applicant
John O. Butler Co.
4635 W Foster Ave.
Chicago,  IL  60630
Applicant Contact CHRISTY CALHOON
Correspondent
John O. Butler Co.
4635 W Foster Ave.
Chicago,  IL  60630
Correspondent Contact CHRISTY CALHOON
Regulation Number872.6390
Classification Product Code
JES  
Date Received05/03/1995
Decision Date 06/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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