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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retainer, Matrix
510(k) Number K091533
Device Name SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
Applicant
Garrison Dental Solutions
80 Shelton Technology Center
Shelton,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
Garrison Dental Solutions
80 Shelton Technology Center
Shelton,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number872.4565
Classification Product Code
JEP  
Date Received05/26/2009
Decision Date 08/17/2009
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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