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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lock, Wire, And Ligature, Intraoral
510(k) Number K031207
Device Name SAFETY RELEASE ARCH BAR KIT
Applicant
Casey Surgical, LLC
200 NE Mulberry, Suite 200
Lee'S Summit,  MO  64086
Applicant Contact JAMES E STANLEY
Correspondent
Casey Surgical, LLC
200 NE Mulberry, Suite 200
Lee'S Summit,  MO  64086
Correspondent Contact JAMES E STANLEY
Regulation Number872.4600
Classification Product Code
DYX  
Date Received04/16/2003
Decision Date 07/15/2003
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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