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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K071970
Device Name CLEAR IMAGE ALIGNER
Applicant
Specialty Appliance Works, Inc.
2193 Spear Point Dr.
Marietta,  GA  30062
Applicant Contact JAMES W KOLKA
Correspondent
Specialty Appliance Works, Inc.
2193 Spear Point Dr.
Marietta,  GA  30062
Correspondent Contact JAMES W KOLKA
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/17/2007
Decision Date 09/25/2007
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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