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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 K111978
Device Name SULCUS BLUE
Applicant
PRODUITS DENTAIRES PIERRE ROLLAND
124 GAITHER DRIVE
SUITE 140
MT. LAUREL,  NJ  08054
Applicant Contact RICK ROSATI
Correspondent
PRODUITS DENTAIRES PIERRE ROLLAND
124 GAITHER DRIVE
SUITE 140
MT. LAUREL,  NJ  08054
Correspondent Contact RICK ROSATI
Classification Product Code
MVL  
Date Received07/12/2011
Decision Date 10/13/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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