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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clasp, Preformed
510(k) Number K854765
Device Name INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH
Applicant
C&C Systems, Inc.
Heckman, Edward Korwek
1150 17th St. NW Suite 1000
Washington,  DC  20036
Applicant Contact KELLER AND
Correspondent
C&C Systems, Inc.
Heckman, Edward Korwek
1150 17th St. NW Suite 1000
Washington,  DC  20036
Correspondent Contact KELLER AND
Regulation Number872.3285
Classification Product Code
EHP  
Date Received11/27/1985
Decision Date 06/13/1986
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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