SULCUS BLUE


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

Correspodent Contact rick rosati
Classification Product Code
MVL  
Date Received 07/12/2011
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