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FDA 510(k) Application Details - K111978
Device Classification Name
Cord, Retraction
More FDA Info for this Device
510(K) Number
K111978
Device Name
Cord, Retraction
Applicant
PRODUITS DENTAIRES PIERRE ROLLAND
124 GAITHER DRIVE
SUITE 140
MT. LAUREL, NJ 08054 US
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Contact
RICK ROSATI
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MVL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/12/2011
Decision Date
10/13/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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