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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K093711
Device Name RACEGEL
Applicant
SEPTODONT
1050 CONNECTICUT AVE., NW
WASHINGTON,  DC  20036
Applicant Contact WAYNE MATELSKI, ESQ
Correspondent
SEPTODONT
1050 CONNECTICUT AVE., NW
WASHINGTON,  DC  20036
Correspondent Contact WAYNE MATELSKI, ESQ
Classification Product Code
MVL  
Date Received12/01/2009
Decision Date 02/17/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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