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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
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